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Adverse Event Report

DEPUY ACROMED, INC. VSP SPINAL SYSTEM PEDICLE SCREW   back to search results
Catalog Number 2223-2840
Event Date 09/01/2001
Event Type  Other   Patient Outcome  Other;
Event Description

It was reported to depuy acromed that a vsp screw broke post-operatively the screw was implanted in 2001. The screw has not been explanted. The lot number was not reported by the complaintant. No further action can be taken at this time.

 
Manufacturer Narrative

It was reported to depuy acromed that a vsp screw broke post-operatively. The screw was implanted in 2001. The screw has not been explanted. The lot number was not reported by the complainant. No further action can be taken at this time.

 
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Brand NameVSP SPINAL SYSTEM
Type of DevicePEDICLE SCREW
Baseline Brand NameACROMED PEDICLE SCREWS, TITANIUM
Baseline Generic NamePEDICLE SCREW
Baseline Catalogue Number2223-2840
Baseline Device FamilyPEDICLE SCREW
Baseline Device 510(K) NumberK860017
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Date First Marketed02/18/1986
Manufacturer (Section F)
DEPUY ACROMED, INC.
325 paramount dr.
raynham MA 02767
Manufacturer (Section D)
DEPUY ACROMED, INC.
325 paramount dr.
raynham MA 02767
Manufacturer Contact
325 paramount drive
raynham , MA 02767
(508) 880 -8100
Device Event Key367330
MDR Report Key378283
Event Key357008
Report Number1526439-2002-00010
Device Sequence Number1
Product CodeMCV
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/21/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/21/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number2223-2840
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/13/2002
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on February 28, 2009

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