BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® TITANIUM LARGE HEXED SCREW

    MDR report key: 12292463 · Received August 9, 2021

    Report

    Report Number
    0001038806-2021-01469
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Report Date
    December 22, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    UDI-DI
    00844868006138
    PMA / PMN Number
    K972444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. G3: DATE RECEIVED BY THE 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 LARGE HEXED SCREW (ILRGHT) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED FRACTURE AROUND THE THREADS. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE PRODUCT WAS FRACTURED. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE DEVICE WAS INTENDED FOR TOOTH LOCATIONS 14. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENT 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: DHR REVIEW FOR THE LOT (1243232) 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 (1243232) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: FUNCTIONAL: FRACTURE: SCREW) AND NO OTHER COMPLAINTS WERE IDENTIFIED. POST MARKET TRENDING REVIEW: OCTOBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT. 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

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. DATE OF EVENT UNKNOWN / NOT PROVIDED. PREMARKET IDENTIFICATION K072642. DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    THE DOCTOR REPORTS A SCREW FRACTURE IN DENTAL POSITION #14.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190464 CERTAIN® TITANIUM LARGE HEXED SCREW DENTAL SCREW DZE BIOMET 3I ILRGHT 1243232 00844868006138

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female