BEUDAMED
    FDA Adverse Event Injury Summary report: N

    "2.4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW

    MDR report key: 7526903 · Received May 18, 2018

    Report

    Report Number
    0001032347-2018-00289
    Event Type
    Injury
    Date Received
    May 18, 2018
    Date of Event
    December 6, 2017
    Report Date
    October 31, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    PK001238
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THESE PARTS WERE REMOVED IN A REVISION; THEREFORE THE COMPLAINT IS CONSIDERED CONFIRMED. THE FACILITY PROVIDED THAT DEVIATION WHICH WASN¿T ABLE TO BE CORRECTED WITH CONSERVATIVE TREATMENT SO THE RIGHT SIDE HAD TO BE REVISED. THE MEANING OF THIS IS UNCLEAR AND NO ADDITIONAL INFORMATION OR EXPLANATION WAS PROVIDED. NO PRODUCT WAS RETURNED AND NO FUNCTIONAL TESTS OR INSPECTIONS COULD BE PERFORMED. NO X-RAY'S, SCANS, PICTURES, OR PHYSICIANS WERE PROVIDED. DEVICE HISTORY RECORD (DHR) FOR THE MANDIBULAR COMPONENT WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED FOR THE SCREWS AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2018-00288-1.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED TO DOCUMENT THE COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET MICROFIXATION TMJ SYSTEM RIGHT STANDARD OFFSET MANDIBULAR COMPONENT CATALOG # 24-6645 LOT #: 580990B, THERAPY DATE: (B)(6) 2017. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2018-00288.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A REVISION OF THE MANDIBULAR COMPONENT DUE TO A PATIENT DEVIATION WHICH WASN'T ABLE TO BE CORRECTED WITH CONSERVATIVE TREATMENT, THEREFORE THE RIGHT SIDE HAD TO BE REVISED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368943 "2.4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW BONE SCREW HWC BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R