BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 6M M 5.7MM 13MM

    MDR report key: 19509584 · Received June 11, 2024

    Report

    Report Number
    0002023141-2024-01919
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    October 2, 2023
    Report Date
    October 28, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019393
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A1: PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED A2: AGE AT TIME OF THE EVENT UNKNOWN / NOT PROVIDED A3: GENDER UNKNOWN / NOT PROVIDED A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED D4: ADDITIONAL DEVICE INFORMATION UNKNOWN / NOT PROVIDED E1: REPORTER NAME UNKNOWN / NOT PROVIDED G4: PREMARKET IDENTIFICATION K011028/K013227 H4: DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). ZIMVIE RECEIVED ONE (1) TSV6B13, (IMPL TAPERED SCR-V SBM 6M M 5.7MM 13MM) FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICE IDENTIFIED THE IMPLANT WITH SIGNS OF USE, AND THE IMPLANT WAS ATTACHED TO THE MOUNT. THE MOUNT WOULDN¿T DISENGAGE/RELEASE FROM THE IMPLANT AS INTENDED, DURING A FUNCTIONAL TEST. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1252053. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1252053 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DOES NOT DISENGAGE/RELEASE. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSES DETERMINED FROM THE INVESTIGATION ARE INCORRECT TECHNIQUES USED DURING IMPLANT PLACEMENT - CUSTOMER ERROR. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE REPORTED EVENT WAS CONFIRMED WITH ALL THE AVAILABLE INFORMATION. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED. AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED, THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION. H3 OTHER TEXT: INVESTIGATION COMPLETED.

    Description of Event or Problem · 0

    DOCTOR REPORTED IT IS IMPOSSIBLE TO UNSCREW THE MOUNT FROM THE IMPLANT. DOCTOR CONFIRMED PROCEDURE COMPLETED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823277 IMPL TAPERED SCR-V SBM 6M M 5.7MM 13MM DENTAL IMPLANT DZE ZIMMER DENTAL 1252053 00889024019393

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose