BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAIN® TITANIUM LARGE HEXED SCREW

    MDR report key: 8537024 · Received April 22, 2019

    Report

    Report Number
    0001038806-2019-00349
    Event Type
    Injury
    Date Received
    April 22, 2019
    Date of Event
    March 16, 2019
    Report Date
    July 17, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K972444
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FRACTURED PIECES OF THE RETURNED SCREW WERE RETURNED INSIDE OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 13MM (INT413) FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED THAT THE IMPLANT IS BADLY WORN FROM REMOVAL AND A THE IMPLANT APPEARS TO HAVE BEEN TREPHINED OUT. THE INTERNAL DRIVE FEATURE IS CONFIRMED TO CONTAIN THE REPORTED SCREW (ILRGHT), WHICH WAS TOO BADLY DAMAGED TO BE REMOVED. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED DEVICE WAS USED FOR APPROXIMATELY 4 YEARS. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1186622-CN). 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 (1186622-CN) FOR SIMILAR CAUSE AND 2 OTHER COMPLAINTS WERE IDENTIFIED. APRIL POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT(S) (SCREW FRACTURE) OR DEVICE(S) (ILRGHT). THEREFORE, BASED ON THE EVALUATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED FOLLOWING INSPECTION. THE MOST PROBABLE CAUSE FOR THE EVENT IS PATIENT PARAFUNCTION OVER THE COURSE OF 4 YEARS. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: (UDI) NUMBER: (B)(4).

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT WEIGHT: NOT PROVIDED. INITIAL REPORTER FAX NUMBER: NOT PROVIDED. PMA/510(K) NUMBER: K072642.

    Description of Event or Problem · 1

    IT WAS REPORTED A FRACTURED SCREW (ILRGHT) INSIDE THE IMPLANT. SCREW COULD NOT BE REMOVED; THEREFORE, IMPLANT WAS REMOVED. TOOTH LOCATION 14.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330369 CERTAIN® TITANIUM LARGE HEXED SCREW SCREW DZE BIOMET 3I 1186622-CN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention INT413| INT413