BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.1,11.5,MTX,MG

    MDR report key: 10155257 · Received June 15, 2020

    Report

    Report Number
    0002023141-2020-00903
    Event Type
    Malfunction
    Date Received
    June 15, 2020
    Date of Event
    May 21, 2020
    Report Date
    July 27, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019836
    PMA / PMN Number
    K101977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE TAPERED SCREW-VENT IMPLANT (TSVT4B11) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THAT THE DEVICE WAS IN GOOD CONDITION (IMAGES 1 & 2). FUNCTIONAL TESTING WAS PERFORMED USING AN IN-HOUSE HEALING COLLAR. THE HEALING COLLAR WAS ABLE TO TORQUE EASILY INTO THE IMPLANT (IMAGE 3). NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED DEVICE WAS BEING PLACED ON TOOTH #21 (UNKNOWN NOTATION SYSTEM) WHEN THE INCIDENT OCCURRED. X-RAY AND PICTURE IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW FOR THE LOT (1233730) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMMER BIOMET. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT (1233730) AND NO SIMILAR EVENT OR COMPLAINT WAS FOUND. BASED ON THE AVAILABLE INFORMATION AND FUNCTIONAL TESTING, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT (DAMAGED IMPLANT THREADS) WAS UNCONFIRMED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. G4: DATE RECEIVED BY MANUFACTURER. G7: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H3: CHANGED "NO" TO "YES". H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT TOOTH LOCATION # 21, CLINICIAN TRIED MULTIPLE UNKNOWN HEALING COLLARS AND THEY WOULD NOT THREAD ON TO IMPLANT. DOCTOR FEELS THE IMPLANT WAS STRIPPED. HAD TO USE A DIFFERENT IMPLANT TO COMPLETE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616123 IMP,TSV,4.1,11.5,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVT4B11 1233730 00889024019836

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention