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Adverse Event Report

CALCITEK ABUTMENT: SHOULDERED, 2MM, INTEGRAL, 3.25 SCREW RETAINED DENTAL ABUTMENT   back to search results
Catalog Number (2)0612
Event Date 11/11/1996
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Dr reported that two abutments broke in function. Pt is reportedly fine.

 
Manufacturer Narrative

No observable defects could be found with the components themselves. Measurements taken met design requirements. Review of the lot histories of the subject products could not be completed since the lot numbers was unavailable from the doctor's office.

 
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Brand NameABUTMENT: SHOULDERED, 2MM, INTEGRAL, 3.25
Type of DeviceSCREW RETAINED DENTAL ABUTMENT
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
CALCITEK
2320 faraday ave.
carlsbad CA 92008
Manufacturer (Section D)
CALCITEK
2320 faraday ave.
carlsbad CA 92008
Manufacturer (Section G)
ZIMMER DENTAL INC.
1900 aston ave.
carlsbad CA 92008 7308
Device Event Key61441
MDR Report Key61065
Event Key57422
Report Number2023141-1996-00430
Device Sequence Number1
Product CodeDZE
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation DENTIST
Type of Report Initial,Followup,Followup
Report Date 12/11/1996
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/09/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number(2)0612
Device LOT Number(2) UNK
Was Device Available For Evaluation? Device Returned To Manufacturer
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Agena
Event Location Outpatient Treatment Facility
Date Manufacturer Received12/11/1996
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on December 31, 2008

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