BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 11994940 · Received June 14, 2021

    Report

    Report Number
    0002023141-2021-01528
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    April 3, 2021
    Report Date
    October 15, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020085
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM (TSVWB8) IMPLANT WITH COVER SCREW WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED NO APPARENT MALFUNCTION. THE DEVICE COULD NOT BE FUNCTIONALLY TESTED FOR THE REPORTED FAILURES (PERFORATED SINUS) AS IT IS MEDICAL EVENT. HOWEVER, MEASUREMENTS WERE TAKEN. PRE-EXISTING PATIENT CONDITIONS NOTED ON THE PER WERE TYPE IV (LOW) BONE DENSITY & OSTEOPOROSIS. THE REPORTED DEVICE WAS BEING PLACED ON TOOTH # 3 (UNIVERSAL) FOR ABOUT 2 MONTHS 2 WEEKS. X-RAY OR PICTURE IMAGES WERE NOT PROVIDED. THEREFORE, THE REPORTED EVENT COULD NOT BE VERIFIED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1233652. 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 BY LOT NUMBER (1233652) WAS PERFORMED FOR SIMILAR EVENT AND NO OTHER SIMILAR COMPLAINT WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION AND DIMENSIONAL ANALYSIS, DEVICE MALFUNCTION DID NOT OCCUR. ADDITIONALLY, THE REPORTED EVENTS COULD NOT BE VERIFIED SINCE THEY WERE MEDICAL CONDITIONS AND NO X-RAY OR PICTORIAL EVIDENCE WAS AVAILABLE. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. D9: DEVICE AVAILABILITY . G3: DATE RECEIVED BY MANUFACTURER. G6: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H3: CHANGED "NO" TO "YES". H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE.

    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). PMA/510K: K011028, K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT IN SITE 3 WAS REMOVED DUE TO BONE LOSS AND SINUS PERFORATION. SITE WAS GRAFTED WITH ALLOGRAFT PRIOR TO IMPLANT PLACEMENT. PATIENT HAS A HISTORY OF OSTEOPOROSIS AND WILL RETURN IN FUTURE FOR NEW IMPLANT. SYMPTOMS ASSOCIATED WITH EVENT: INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889692 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM DENTAL INPLANT DZE ZIMMER DENTAL TSVWB8 1233652 00889024020085

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention