BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK HEALING ABUTMENT

    MDR report key: 9363568 · Received November 22, 2019

    Report

    Report Number
    0002023141-2019-01159
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Date of Event
    October 23, 2019
    Report Date
    January 10, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). THE UNKNOWN HEALING ABUTMENT AND THE ASSOCIATED TAPERED SCREW-VENT IMPLANT WITH MTX SURFACE (TSVWB8) WERE NOT RETURNED FOR INVESTIGATION. THEREFORE, VISUAL INSPECTION COULD NOT BE PERFORMED. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE PRODUCTS WERE NOT RETURNED. DOCTOR WAS ATTEMPTING TO PLACE DEVICES ON TOOTH # 20 (UNIVERSAL) WHEN THE INCIDENTS OCCURRED. X-RAY OR PICTURE IMAGES WERE NOT PROVIDED AND NO OTHER INFORMATION WAS PROVIDED. NO DEVICE LOT NUMBER WAS PROVIDED FOR THE UNKNOWN HEALING ABUTMENT SO A DEVICE HISTORY RECORD REVIEW AND A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. DHR (DEVICE HISTORY REVIEW) REVIEW FOR THE ASSOCIATED DEVICE TSVWB8 AND LOT (1220043) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. 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 LOT (1220043) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. COMPLAINANT REPORTED THAT THE IMPLANT COULDN¿T SEAT HEALING ABUTMENT BECAUSE OF DAMAGED INTERNAL THREADS. THE PRODUCTS WERE NOT RETURNED. THEREFORE, THE REPORTED COMPLAINT COULD NOT BE VERIFIED. A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALING ABUTMENT COULD NOT BE SEATED BECAUSE THE INTERNAL THREADS OF THE IMPLANT WERE STRIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160558 UNK HEALING ABUTMENT HEALING ABUTMENT NHA ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 TSVWB8