BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12244735 · Received July 29, 2021

    Report

    Report Number
    0002023141-2021-01952
    Event Type
    Injury
    Date Received
    July 29, 2021
    Date of Event
    March 8, 2021
    Report Date
    December 17, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019508
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. D9: DEVICE AVAILABLE FOR EVALUATION CHANGE ¿NO' TO 'YES'. G3: DATE RECEIVED BY THE MANUFACTURER. H1: TYPE OF REPORT, FOLLOW-UP NUMBER. H2: FOLLOW UP TYPE. H6: EVALUATION CODES. H10: ADDITIONAL NARRATIVE DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1230358). 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 WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1230358) FOR SIMILAR EVENTS (KEYWORD CATEGORY: DENTAL: MEDICAL: BONE LOSS) AND NO OTHER COMPLAINT WAS IDENTIFIED

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED, PMA/510(K) NUMBER K011028 AND K013227. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR BONE LOSS EVENTS RECOGNIZING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO A WIDE RANGE OF EXTERNAL FACTORS (NON-DESIGN OR MANUFACTURING RELATED), INCLUDING MEDICAL CONDITIONS (E.G., DIABETES, POOR BONE QUALITY, ETC.) / PATIENT HABITS (E.G., SMOKING) AND SURGICAL TECHNIQUE. PREVIOUSLY COMPLETED INVESTIGATIONS FOR BONE LOSS HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCE AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF MANUFACTURING OR DESIGN DEFECTS THAT MIGHT LEAD TO BONE LOSS AND ESCAPING THE AVAILABLE DETECTIONS HAS BEEN ASSESSED AND FOUND REMOTE AND ALMOST NONEXISTENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPLANT WAS REMOVED DUE TO BONE LOSS. 5 MONTHS LATER THE PATIENT BACK FOR A REVIEW WITH SOME PAIN, THE TEST SHOWED THAT THERE WAS BONE LOSS, THE IMPLANT WAS REMOVED AND A NEW IMPLANT WAS IMPLANTED THE SAME DAY WITH A BIOS BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146236 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB10 1230358 00889024019508

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention