BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN TITANIUM HEXED SCREW

    MDR report key: 11090325 · Received December 29, 2020

    Report

    Report Number
    0001038806-2020-02162
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    November 13, 2020
    Report Date
    April 7, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868008545
    PMA / PMN Number
    K072642
    Removal / Correction Number
    N/A
    Product Problem
    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: A1 PATIENT IDENTIFIER UPDATED TO UNKNOWN B4: DATE OF THIS REPORT B5: DESCRIBE EVENT OR PROBLEM D4: EXPIRATION DATE 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 CERTAIN® TITANIUM HEXED SCREW (IUNIHT) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THAT IT WAS FRACTURED ACROSS THE THREADS. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE DEVICE WAS FRACTURED.PRE-EXISTING CONDITIONS NOTED ON THE PER WAS NONE. HOWEVER, SCREW WAS IMPLANTED ON TOOTH LOCATION 25 (FDI) AND PLACED FOR APPROXIMATELY 5 MONTHS. X-RAY OR PICTURE IMAGES WERE NOT PROVIDED. DOCUMENTS REVIEWED: BIOMET 3I RESTORATIVE PRODUCTS IFU (P-IIS086GR) REV F - OCTOBER 2019. PER THE APPLICABLE IFU, IT IS STATED THAT IMPROPER TECHNIQUE CAN LEAD TO DEVICE FAILURE. ADDITIONALLY, BREAKAGE MAY OCCUR WHEN DEVICE IS LOADED BEYOND ITS FUNCTIONAL CAPABILITY. DHR REVIEW FOR THE LOT NUMBER (1230841) 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. COMPLAINT HISTORY REVIEW BY LOT NUMBER (1230841) WAS PERFORMED FOR SIMILAR EVENTS AND NO OTHER SIMILAR COMPLAINT WAS IDENTIFIED. MONTHLY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (FUNCTIONAL: FRACTURE: SCREW) OR PRODUCT (IUNIHT). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW PLACED AT TOOTH SITE #25 FRACTURED AND WAS COMPLETELY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552514 CERTAIN TITANIUM HEXED SCREW ABUTMENT SCREW NHA BIOMET 3I IUNIHT 1230841 00844868008545

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR