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Adverse Event Report

ETEX CORPORATION BSM BONE SUBSTITUTE MATERIAL BONE GRAFT MATERIAL, BONE SUBSTITUTE   back to search results
Lot Number 100215
Event Date 09/08/2000
Event Type  Other   Patient Outcome  Required Intervention;
Event Description

Diagnosis: fracture of distal radius: toxic local reaction about 48 hours after implantation: swelling, reddening, pain of the operated area, clinically signs of a severe and acute infection. No increased lab values for inflammatory reaction, microscopically plenty of granulocytes, no bacteria, bacterial culture negative; after removal of not specified material from the drainage recurrence of symptoms. This case was reported to the austrian health authority (bmsg). Relevant concomitant disease: not reported; surgery: open reposition with drill wires and external fixation and implantation of biobon; drains; smears negative. Only 50% of the defect was filled with biobon, no mixture with other materials, after mixing biobon showed a pasty consistency, manual implantation directly after mixing, the implantation cavity was dry; it was not checked whether biobon was hardened before wound closure; duration between implantation and wound closure was 5 minutes. Postoperative follow-up: about 48 hours after surgery reddening, swelling, clinical signs of infection; no physical load on the fracture/defect; after the removal of the drain with small white particles (probably biobon) the hematoma disappeared. The bacteriology was negative, normal values of leucocytes were found. Antibiotic treatment with augmentin was performed, the wound area was locally treated with icebags. The symptoms disappeared after two days.

 
Manufacturer Narrative

This incident relates to the use of a device which is released in europe for orthopedic use. It is not currently in us commercial distribution for orthopedic use. A distribution partner distributes the device in europe. The distributor indicates that this case has been reported to the austrian health authority (bmsg).

 
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Brand NameBSM BONE SUBSTITUTE MATERIAL
Type of DeviceBONE GRAFT MATERIAL, BONE SUBSTITUTE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ETEX CORPORATION
350 mass. ave
cambridge MA 02139
Manufacturer (Section D)
ETEX CORPORATION
350 mass. ave
cambridge MA 02139
Manufacturer Contact
pamela adams
350 massachusetts ave
cambridge , MA 02139
(617) 577 -7270
Device Event Key293456
MDR Report Key303209
Event Key284908
Report Number1225112-2000-00005
Device Sequence Number1
Product CodeLMN
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 10/26/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/30/2000
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date12/01/2001
Device LOT Number100215
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/22/2000
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2000
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device? No Answer Provided
Type of Device Usage Initial

Database last updated on February 28, 2009

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