BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM

    MDR report key: 11086232 · Received December 29, 2020

    Report

    Report Number
    0002023141-2020-02418
    Event Type
    Injury
    Date Received
    December 29, 2020
    Date of Event
    November 27, 2019
    Report Date
    April 7, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019515
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    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. G3: DATE RECEIVED BY MANUFACTURER. H1: TYPE OF REPORT, FOLLOW-UP NUMBER. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES'. H6: EVALUATION CODES. H10: ADDITIONAL NARRATIVE. ONE (1) IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM (TSVB11) WAS RETURNED FOR INVESTIGATION (IMAGE ATTACHED IN COMPLAINT). VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED NO APPARENT MALFUNCTION. SIGNS OF USE AND BONE PIECES ON THE EXTERNAL THREADS ONLY. PRODUCT MATCHED PRINT SPECIFICATION WHERE MEASURED. 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 LOW BONE DENSITY (TYPE III). THE REPORTED DEVICE WAS LOCATED ON TOOTH # 14 (UNIVERSAL) AND WAS IMPLANTED AND REMOVED ON THE SAME DAY. THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR X-RAYS. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: (B)(4) REV 9-10/2019; ADVERSE EFFECTS; PAGE 2. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER: (1221637). 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: (1221637) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. JANUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (BONE FRACTURE) OR PRODUCT (TSVB11). NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS NOT OCCURRED AND THE REPORTED EVENT IS NON-VERIFIABLE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). PMA/510(K) NUMBERK013227.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE PROCEDURE WHILE DOCTOR WAS PLACING THE IMPLANT THE VESTIBULAR WALL FRACTURED. THE IMPLANT WAS REMOVED. DOCTOR PERFORMED BONE GRAFT (XENOGRAFT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553942 IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB11 1221637 00889024019515

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention