BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM

    MDR report key: 11257350 · Received February 1, 2021

    Report

    Report Number
    0002023141-2021-00225
    Event Type
    Injury
    Date Received
    February 1, 2021
    Report Date
    May 18, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER: (B)(4). ONE TAPERED SCREW-VENT IMPLANT (TSVB11) AND ONE UNKNOWN THREPHINE BURR WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED FRACTURE/DAMAGES AROUND THE COLLAR OF THE IMPLANT AND THE LOWER PORTION OF THE TOOL. DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED SINCE THE LOT NUMBERS WERE UNKNOWN. HOWEVER, ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCTS. AN ITEM-BASED (TSVB11) COMPLAINT HISTORY REVIEW OVER A ONE-YEAR PERIOD WAS PERFORMED FOR SIMILAR EVENTS AND NO COMPLAINTS ABOUT NONCONFORMING PRODUCTS WERE IDENTIFIED. HOWEVER, COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED FOR THE UNKNOWN THREPHINE BURR SINCE THE LOT/ITEM NUMBER WAS UNKNOWN. THEREFORE, 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

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. LOT AND UDI NUMBER UNKNOWN / NOT PROVIDED. LAST NAME UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER:K013227.

    Description of Event or Problem · 1

    DOCTOR REPORTED THE TOP OF THE IMPLANT FRACTURED AND WAS REMOVED. FLOWERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157869 IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention