BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 11249786 · Received January 29, 2021

    Report

    Report Number
    0002023141-2021-00202
    Event Type
    Injury
    Date Received
    January 29, 2021
    Date of Event
    December 29, 2019
    Report Date
    May 18, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019508
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER CMP-0664266 THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT B5: DESCRIBE EVENT OR PROBLEM D9: DEVICE AVAILABILITY G3: DATE RECEIVED BY MANUFACTURER G6: TYPE OF REPORT H1: TYPE OF REPORTABLE EVENT H2: FOLLOW UP TYPE H3: DEVICE EVALUATED BY MANUFACTURER H4: DEVICE MANUFACTURER DATE H6: ADVERSE EVENT PROBLEM H10: ADDITIONAL NARRATIVE ONE TAPERED SCREW-VENT IMPLANT (TSVB10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE (BONE RESIDUE) BUT NO APPARENT SIGNS OF MALFUNCTION. THE DEVICE COULD NOT BE FUNCTIONALLY TESTED FOR THE REPORTED FAILURE (PAIN). HOWEVER, MEASUREMENTS WERE TAKEN USING A CALIPE. FOLLOWING DIMENSIONAL ANALYSIS AND COMPARISON TO DRAWINGS, THE DEVICE WAS DETERMINED TO BE WITHIN DESIGN SPECIFICATION. DEVICE HISTORY REVIEW (DHR) REVIEW FOR THE LOT (1223469) 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 (1223469) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT ABOUT NONCONFORMING PRODUCTS WERE IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR. HOWEVER, THE REPORTED EVENT COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT WERE NONVERIFIABLE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER: K011028 AND K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 9 DAYS AFTER PLACEMENT IMPLANT WAS REMOVED DUE TO PAIN AND NUMBNESS OF THE LOWER LIP. AFTER REMOVAL, THESE SENSATIONS PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149180 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB10 1223469 00889024019508

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention