BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10325224 · Received July 27, 2020

    Report

    Report Number
    0002023141-2020-01124
    Event Type
    Malfunction
    Date Received
    July 27, 2020
    Date of Event
    November 5, 2019
    Report Date
    December 17, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019515
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. D4: ADDITIONAL DEVICE INFORMATION UNKNOWN / NOT PROVIDED. G4: DATE RECEIVED BY MANUFACTURER . G5: PREMARKET IDENTIFICATION PMA/510(K) NUMBER K013227. G7: TYPE OF REPORT, FOLLOW-UP NUMBER. H1: TYPE OF REPORTABLE EVENT. H2: FOLLOW UP TYPE . H3: DEVICE EVALUATED BY MANUFACTURER. H4: DEVICE MANUFACTURER DATE. H6: EVENT PROBLEM AND EVALUATION CODES. H10: ADDITIONAL NARRATIVE. ONE TAPERED SCREW-VENT IMPLANT (TSVH11) WAS RETURNED FOR INVESTIGATION . VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THAT THE COLLAR WAS FRACTURED OFF POSSIBLY DUE TO THE REMOVAL PROCESS DOCTOR REPORTED THAT THE MOUNT WAS STUCK AND THE IMPLANT HAD TO UNDERGO GUIDED FORCED REMOVAL. ADDITIONALLY, THERE WAS BONE RESIDUE AROUND THE EXTERNAL THREADS DUE TO USAGE. DEVICE HISTORY RECORD (DHR) REVIEW FOR THE LOT (1222189) 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 THE LOT (1222189) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, AN UNREPORTED MALFUNCTION DID OCCUR (FRACTURE). HOWEVER, THE REPORTED EVENT (MOUNT DOES NOT DISENGAGE) COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT WERE NONVERIFIABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). IMPLANT DATE UNKNOWN / NOT PROVIDED, EXPLANT DATE UNKNOWN / NOT PROVIDED, EMAIL ADDRESS UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER: K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MOUN GOT STUCK INTO THE IMPLANT AND IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792787 IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB11 1222189 00889024019515

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention