BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT X-DRIVE SCREW

    MDR report key: 5003132 · Received August 14, 2015

    Report

    Report Number
    0001032347-2015-00349
    Event Type
    Injury
    Date Received
    August 14, 2015
    Date of Event
    July 13, 2015
    Report Date
    July 15, 2015
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    PK001238
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. THE SCREWS WERE DISCARDED, THEREFORE NO PRODUCT EVALUATION CAN BE PERFORMED. THERE IS NO INDICATION THE SCREWS DID NOT FUNCTION AS INTENDED, THEY WERE EXPLANTED AS A RESULT OF THE TMJ COMPONENTS BEING EXPLANTED. 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. REPORT SIX OF SIX FOR THE SAME EVENT, SEE ALSO 1032347-2015-00344, 1032347-2015-00345, 1032347-2015-003476, 1032347-2015-00347 AND 1032347-2015-00348.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON STATED IT SEEMS THAT THE MANDIBULAR COMPONENT OF THE PATIENT MATCHED IMPLANT WAS TOO LONG, THEREFORE, THERE WAS TOO MUCH PRESSURE ON THE JOINT. IT IS REPORTED AFTER SURGERY THE PATIENT HAD STRONG PAIN. ON (B)(6) 2015 THERE WAS A REVISION SURGERY TO REMOVE THE PATIENT MATCHED TMJ IMPLANT AND IMPLANT A STOCK PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538192 HT X-DRIVE SCREW BONE SCREW HWC BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R