BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM

    MDR report key: 12677367 · Received October 21, 2021

    Report

    Report Number
    0002023141-2021-02955
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    September 21, 2021
    Report Date
    April 14, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020085
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE (1) IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM (TSVWB8) WAS RETURNED FOR INVESTIGATION. . VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THE IMPLANT WITH A TOOL ATTACHED, MOST LIKELY STUCK DURING THE REMOVAL PROCESS. SOME SIGNS OF MINOR DAMAGE TO THE IMPLANT. THE UNKNOWN ABUTMENT WAS NOT RETURNED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. A PRE-EXISTING CONDITION NOTED ON THE PER WAS HIGH BONE DENSITY (TYPE I). THE REPORTED DEVICE WAS LOCATED ON TOOTH # 18 (UNIVERSAL) AND WAS PLACED AND REMOVED ON THE SAME DAY. THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR X-RAYS. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1243608). 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. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. DHR REVIEW: UNK ABUTMENT: DHR REVIEW AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED, AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT IS NOT AVAILABLE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO PREVENT THE DISTRIBUTION OF NON-CONFORMING PRODUCT IS WITHIN SPECIFICATIONS. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1243608) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT WEIGHT UNKNOWN / NOT PROVIDED. LOT/SERIAL # UNKNOWN / NOT PROVIDED. DEVICE EXPIRATION DATE UNKNOWN / NOT PROVIDED. DEVICE UDI NUMBER UNKNOWN / NOT PROVIDED. PMA/510K: K011028, K013227. DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT INTERNAL THREAD DEFECT - ABUTMENT WOULD NOT SEAT CORRECTLY. THE DEFECTIVE IMPLANT WAS REMOVED AND REPLACED WITH A NEW ONE. AS A RESULT OF THIS EVENT, NO INJURY TO THE PATIENT REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: NONE REPORTED. TOOTH # 18.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1573239 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWB8 1243608 00889024020085

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention