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Adverse Event Report

CALCITEK, INC TEMPORARY GINGIVAL CUFF: 5MM, 4.5 CUFF, SPIN, 3.25 TEMORARYY GINGIVAL CUFF FAMILY   back to search results
Catalog Number 1800
Event Date 10/30/1996
Event Type  Injury   Patient Outcome  Required Intervention;
Manufacturer Narrative

No observable defects could be found with the component itself. Measurements taken met design requirements. Review of the lot history of the subject product could not be completed since the lot number was unavailable from the doctor's office.

 
Event Description

Dr reported that a temporary gingival cuff broke in function. Pt is reportedly fine.

 
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Brand NameTEMPORARY GINGIVAL CUFF: 5MM, 4.5 CUFF, SPIN, 3.25
Type of DeviceTEMORARYY GINGIVAL CUFF FAMILY
Baseline Brand NameTEMPORARY GINGIVAL CUFF: 5MM, 4.5 CUFF, SPIN 3.25
Baseline Generic NameTEMPORARY GINGIVAL CUFF
Baseline Catalogue Number1800
Baseline Device FamilyTEMPORARY GINGIVAL CUFF
Baseline Device 510(K) NumberK900549
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Date First Marketed07/01/1990
Manufacturer (Section F)
CALCITEK, INC
2320 faraday ave.
carlsbad CA 92008
Manufacturer (Section D)
CALCITEK, INC
2320 faraday ave.
carlsbad CA 92008
Manufacturer (Section G)
ZIMMER DENTAL INC.
1900 aston ave.
carlsbad CA 92008 7308
Manufacturer Contact
brenda clancy
2320 faraday ave.
carlsbad , CA 92008
(619) 431 -9515
Device Event Key52008
MDR Report Key51333
Event Key48154
Report Number2023141-1996-00289
Device Sequence Number1
Product CodeDZE
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation DENTIST
Type of Report Initial,Followup
Report Date 10/30/1996
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/26/1996
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number1800
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 Received10/30/1996
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 January 30, 2009

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