BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

    MDR report key: 8843712 · Received July 30, 2019

    Report

    Report Number
    0002023141-2019-00491
    Event Type
    Injury
    Date Received
    July 30, 2019
    Report Date
    November 22, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: 22 NOV 2019. B5: IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS. IMPLANT WAS FRACTURED DURING THE REMOVAL PROCESS. D4: EXPIRATION DATE: 01 SEP 2012. G4: 24 OCT 2019. G7: FOLLOW UP. H1: SERIOUS INJURY. H2: ADDITIONAL INFORMATION, DEVICE EVALUATION. H3: YES, EVALUATION SUMMARY ATTACHED H4: 21 SEP 2007. H6: METHOD, RESULTS, CONCLUSION CODES. H10: MANUFACTURER NARRATIVE. THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PRODUCT IDENTIFIED THAT THE IMPLANT AND SCREW ARE FRACTURED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE REPORTED EVENT. THE REPORTED CONDITION OF BONE LOSS COULD NOT BE CONFIRMED. THE IMPLANT DEVICE AND SCREW ARE CONFIRMED TO BE FRACTURED. IT WAS REPORTED THAT THE IMPLANT AND SCREW WERE FRACTURED DURING THE IMPLANT REMOVAL PROCESS. 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-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WERE NOTED AS PART OF THE DHR. A COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THE REPORTED DEVICE LOT FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE IDENTIFIED. 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

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS. IMPLANT WAS FRACTURED DURING THE REMOVAL PROCESS.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). AGE: NOT PROVIDED. PATIENT WEIGHT: NOT PROVIDED. EVENT DATE: NOT PROVIDED. INITIAL REPORTER FAX NUMBER: NOT PROVIDED. PMA/510(K) NUMBER: K01102, K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANT (TSVB10) WAS REMOVED DUE TO BONE LOSS AT TOOTH LOCATION 18.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637993 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL 60806390

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention