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Adverse Event Report

CALCITEK IMPLANT: HA, 10MM, INTEGRAL OMNILOC 3.25 HA CYLINDER ENDOSSEOUS DENTAL IMPLANT   back to search results
Catalog Number 0609
Event Date 01/07/1997
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Dr reported that an implant failed. Pt is same pt as prior mdr reports m725368, m725369 and medwatch report 2023141-1997-36.

 
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Brand NameIMPLANT: HA, 10MM, INTEGRAL OMNILOC 3.25
Type of DeviceHA CYLINDER ENDOSSEOUS DENTAL IMPLANT
Baseline Brand NameIMPLANT, HA 1MM OMNILOC, 3.25
Baseline Generic NameOMNILOC DENTAL IMPLANT
Baseline Catalogue Number0609
Baseline Device FamilyHA CYLINDER DENTAL IMPLANT
Baseline Device 510(K) NumberK900549
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed07/01/1990
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
sheri engrasci
2320 faraday ave
carlsbad , CA 92008
(619) 431 -9515
Device Event Key67143
MDR Report Key67100
Event Key63085
Report Number2023141-1997-00037
Device Sequence Number1
Product CodeDZE
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation DENTIST
Type of Report Initial
Report Date 01/10/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/07/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number0609
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 Received01/10/1997
Was Device Evaluated By Manufacturer? No
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 February 28, 2009

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