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Adverse Event Report

CALCITEK TEMPORARY GINGIVAL CUFF, 5MM, 103.25   back to search results
Model Number N
Event Date 11/15/1996
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Pt wore denture over temporary gingival cuff and it then broke. Pt is reportedly fine.

 
Manufacturer Narrative

Method (86): part not returned. Lot number not available from dr.

 
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Brand NameTEMPORARY GINGIVAL CUFF, 5MM, 103.25
Type of DeviceTEMPORARY GINGIVAL CUFF
Baseline Brand NameMICRO-VENT IMPLANT HA 5.7X10MML
Baseline Generic NameMICRO-VENT DETNAL IMPLANT
Baseline Catalogue NumberMV5H10
Baseline Model NumberN
Baseline Device FamilyTHREADED ENDOSSEOUS DENTAL IMPLANT
Baseline Device 510(K) NumberK873255
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed03/04/1987
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
Manufacturer Contact
robert quinn
1900 aston ave.
carlsbad , CA 92008
(760) 929 -4118
Device Event Key61247
MDR Report Key60865
Event Key57236
Report Number2023141-1996-00428
Device Sequence Number1
Product CodeDZE
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation DENTIST
Type of Report Initial
Report Date 12/10/1996
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberN
Device Catalogue Number0387
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Agena
Event Location Other
Date Manufacturer Received12/10/1996
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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 January 30, 2009

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