BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SP 4.8MM 10M M OCTAGON

    MDR report key: 10276462 · Received July 15, 2020

    Report

    Report Number
    0002023141-2020-01052
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    May 22, 2020
    Report Date
    December 15, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024017566
    PMA / PMN Number
    K082639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). A IMPL TAPERED SP 4.8MM 10M M OCTAGON (SPWB10) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED SLIGHT BONE ON THREADS AND DAMAGED INTERNAL FEATURE/THREADS. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (2020011479). 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 (2020011479) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. PATIENT SEX UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. EMAIL ADDRESS UNKNOWN / NOT PROVIDED. PMA/510(K) K011245 AND K002188.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT SURGERY THE MOUNT DAMAGED THE IMPLANT THREADS, IMPLANT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742845 IMPL TAPERED SP 4.8MM 10M M OCTAGON DENTAL IMPLANT DZE ZIMMER DENTAL SPWB10 2020011479 00889024017566

    Patients

    Seq Age Sex Outcome Treatment
    1