BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4 MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 2.7 X 10 MM

    MDR report key: 8394427 · Received March 6, 2019

    Report

    Report Number
    0001032347-2019-00146
    Event Type
    Injury
    Date Received
    March 6, 2019
    Date of Event
    January 8, 2019
    Report Date
    May 10, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    UDI-DI
    00841036053642
    PMA / PMN Number
    K113512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF EVIDENCE THAT THE REVISION WAS PERFORMED. NO PRODUCT WAS RETURNED, THEREFORE NO FUNCTIONAL TESTS OR INSPECTIONS COULD BE PERFORMED. NO X-RAYS, SCANS, PICTURES, OR PHYSICIAN'S REPORTS WERE PROVIDED. BECAUSE A REVISION SURGERY OCCURRED, THE COMPLAINT IS CONSIDERED TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2019-00143-1, 0001032347-2019-00144-1, 0001032347-2019-00145-1, 0001032347-2019-00147-1, 0001032347-2019-00148-1.

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 REPORTS: 0001032347-2019-00143 THROUGH 0001032347-2019-00148.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT A REVISION WAS PERFORMED DUE TO A PERSISTENT STAPHYLOCOCCUS INFECTION. THE PATIENT IS ON IV ANTIBIOTICS AND AN ANTIBIOTIC IMPREGNATED SPACER WAS IMPLANTED. NEW IMPLANTS WILL BE PLACED IN APPROXIMATELY ONE MONTH. THE PATIENT ADVISES THE SPACER KEEPS POPPING OUT AND SHE IS EXPERIENCING BAD HEADACHES. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190682 2.4 MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 2.7 X 10 MM SCREW, FIXATION, BONE HWC BIOMET MICROFIXATION N/A UNKNOWN 00841036053642

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R