BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7 X 10 MM HIGH TORQUE CROSS-DRIVE SCREW

    MDR report key: 5676998 · Received May 24, 2016

    Report

    Report Number
    0001032347-2016-00238
    Event Type
    Injury
    Date Received
    May 24, 2016
    Date of Event
    January 13, 2016
    Report Date
    September 26, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    PK001238
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2016-00235-1, 0001032347-2016-00236-1, 0001032347-2016-00237-1, 0001032347-2016-00239-1, 0001032347-2016-00240-1, AND 0001032347-2016-00241-1.

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. BECAUSE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORDS COULD NOT BE PULLED AND REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. THIS IS REPORT 4 OF 7 FOR THE SAME EVENT. REPORTS 1 THROUGH 3, AND 5 THROUGH 7 ARE REPORTED ON MFR #0001032347-2016-00235 THROUGH 0001032347-2016-00237 AND 0001032347-2016-00239 THROUGH 0001032347-2016-00241.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT THAT THE JOINTS WERE PLACED INCORRECTLY DURING SURGERY ON ONE SIDE, BEYOND THE SOCKET AREA. THE REVISED TMJ IMPLANTS WERE REPLACED WITH CUSTOM JOINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BILATERAL REVISION OCCURRED AS A RESULT OF THE IMPLANTS DISLOCATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330348 2.7 X 10 MM HIGH TORQUE CROSS-DRIVE SCREW BONE SCREW HWC BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R