BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM

    MDR report key: 9332066 · Received November 15, 2019

    Report

    Report Number
    0002023141-2019-01101
    Event Type
    Injury
    Date Received
    November 15, 2019
    Date of Event
    September 16, 2019
    Report Date
    January 9, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. B7: BONE DENSITY TYPE WAS ADDED. D4: EXPIRATION DATE AND UNIQUE IDENTIFIER (UDI) NUMBER WERE ADDED. G4: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G7: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER WAS UPDATED. H4: DEVICE MANUFACTURER DATE WAS UPDATED. H6: METHOD CODE WAS UPDATED TO 10, 3331 AND 4109. H6: RESULTS CODE WAS UPDATED TO 180. H6: CONCLUSIONS CODE WAS UPDATED TO 4307. H10: NARRATIVE/DATA WAS UPDATED. THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. THE REPORTED CONDITION OF COVER SCREW STUCK IN IMPLANT WAS CONFIRMED. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF WEAR AND BONE RESIDUE AROUND THE EXTERNAL THREADS DUE TO USAGE. THE REPORTED CONDITION OF BONE LOSS WAS NOT CONFIRMED. FUNCTIONAL TESTING WAS PERFORMED TO DISENGAGE THE COVER SCREW UNSUCCESSFULLY. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE REPORTED DEVICE LOT. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCE, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. A COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THE REPORTED DEVICE LOT FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). INITIAL REPORTER¿S FIRST NAME IS NOT PROVIDED / UNKNOWN. ADDITIONAL 510(K) NUMBERS ARE K011028 AND K013227.

    Description of Event or Problem · 1

    DOCTOR INDICATED THAT DURING A DENTAL SURGERY THEY PLACED THE TSVWB10 IMPLANT AND THE COVER SCREW. DURING THE SAME SURGERY THEY TRIED TO REMOVE THE COVER SCREW. DOCTOR WAS UNABLE TO REMOVE THE COVER SCREW. THE IMPLANT HAD PERFECT PRIMARY STABILITY AND WHILE REMOVING THE IMPLANT, STILL IN THE SAME SURGERY, THE PATIENT EXPERIENCED A BONE LOSS. TOOTH SITE #20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124006 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL 1224872

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention