BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.7,11.5,MTX,MG

    MDR report key: 11437027 · Received March 8, 2021

    Report

    Report Number
    0002023141-2021-00582
    Event Type
    Injury
    Date Received
    March 8, 2021
    Date of Event
    February 8, 2020
    Report Date
    July 27, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMP,TSV,4.7,11.5,MTX,MG (TSVTWB11) WAS RETURNED FOR INVESTIGATION. THE HC455 AND TWO UNKNOWN ABUTMENTS WERE NOT RETURNED FOR INSPECTION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNIFICANT DAMAGE AND DEBRIS ABOUT THE IMPLANT THREADS AND DRIVE FEATURE. FUNCTIONAL TESTING NOTES THAT THE DRIVE FEATURE IS NO LONGER ABLE TO SEAT THREADED COMPONENTS (FUNCTIONAL TESTING). NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED PRODUCT WAS LOCATED ON TOOTH # 3 (UNIVERSAL) AND USED FOR APPROXIMATELY 5 MONTHS. THE CUSTOMER HAS NOT PROVIDED ADDITIONAL PICTURES OR X-RAY IMAGES OF THE PRODUCT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1231160. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1231160) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED UTILIZING KEYWORD(S) DAMAGED DRIVE. MAY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (DAMAGED DRIVE FEATURE & DOES NOT SEAT) OR PRODUCT (TSVTWB11 & HC455). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS OCCURRED AND THE REPORTED EVENT AS IT RELATES TO THE RETURNED IMPLANT WAS CONFIRMED FOLLOWING INSPECTION AND FUNCTIONAL TESTING OF THE DEVICE. FUNCTIONALITY OF THE REPORTED ABUTMENTS AND HEALING COLLAR MALFUNCTION COULD NOT BE VERIFIED WITH THE INFORMATION PROVIDED AS THE DEVICES WERE NOT RETURNED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. NO IMMEDIATE CAPA/HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). PATIENT WEIGHT: NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBER: K101880.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO IMPLANT DAMAGE. SEVERAL HEALING COLLAR/ ABUTMENT WERE ATTEMPTED TO SEAT WITHIN THE IMPLANT WITHOUT SUCCESS. IMPLANT WAS FINALLY REMOVED. TOOTH LOCATION 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337291 IMP,TSV,4.7,11.5,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL 1231160

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention