BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM

    MDR report key: 12832736 · Received November 17, 2021

    Report

    Report Number
    0002023141-2021-03320
    Event Type
    Injury
    Date Received
    November 17, 2021
    Date of Event
    October 22, 2021
    Report Date
    May 11, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019522
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE (1) IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM (TSVB13) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED NO APPARENT MALFUNCTION WITH THE IMPLANT. DRIED BLOOD DEBRIS ON THE EXTERNAL THREADS AND AROUND THE COLLAR. SIGNS OF USE AND MINOR SCRATCHES. PRODUCT MATCHED PRINT SPECIFICATION WHERE MEASURED (CALIPER ID: CAL1831 DUE: SEP 2, 2022) 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 MODERATE BONE DENSITY (TYPE II). THE REPORTED DEVICE WAS LOCATED ON TOOTH # 9 (UNIVERSAL) AND WAS PLACED AND REMOVED ON THE SAME DAY. THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR X-RAYS. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE - TAPERED SCREW-VENT AND TRABECULAR METAL IMPLANTS, IFU4869 REV 9 - 10/19. INFORMATION IDENTIFIED: CONTRAINDICATIONS, WARNINGS, PRECAUTIONS AND BREAKAGE. PER THE APPLICABLE IFU, IT IS STATED THAT IMPROPER TECHNIQUES CAN CAUSE BONE LOSS, PATIENT INJURY, PAIN AND IMPLANT FAILURE. DHR REVIEW: DHR REVIEW FOR THE LOT (1243963) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMMER BIOMET. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1243963) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: MEDICAL: BONE FRACTURE) AND NO OTHER COMPLAINT WAS IDENTIFIED. POST MARKET TRENDING REVIEW: MARCH POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (BONE FRACTURE) OR PRODUCT (TSVB13). NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS NON-VERIFIABLE.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT ID NOT PROVIDED. PATIENT WEIGHT NOT PROVIDED. ADDITIONAL 510(K) NUMBERS ARE K011028 AND K013227.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN PLACING IMPLANT AT TOOTH SITE # 9 A SMALL BONY WALL FRACTURED. IMPLANT WAS REMOVED. SITE BONE GRAFTED. PATIENT NOT RETURNING FOR IMPLANT REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729375 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB13 1243963 00889024019522

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention