BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LORENZ

    MDR report key: 457608 · Received May 1, 2003

    Report

    Report Number
    MW1028322
    Event Type
    Injury
    Date Received
    May 1, 2003
    Date of Event
    October 9, 2002
    Report Date
    April 30, 2003
    Manufacturer
    *
    Product Code
    HXX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHILE AFIXING ORBITOZYGOMATIC OSTEOTOMY, DURING TIGHTENING OF ONE OF THE SCREW-PLATES, THE SCREW DRIVER -LORENZ CO.- SLIPPED AND PENETRATED PT'S BRAIN, CAUSING INTRACEREBRAL HEMATOMA AND BRAIN CONTUSION. A PARTIAL TEMPORAL LOBECTOMY WAS REQUIRED TO REMOVE THE HEMATOMA AND CONTUSION.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR 5/30/03: MFR HAS CONDUCTED A REVIEW OF THEIR COMPLAINT HISTORY AND THEY HAVE NOT RECEIVED ANY REPORTS OF SCREWDRIVERS FAILING ON THE DATES OUTLINED IN THE VOLUNTARY MEDWATCH REPORT THAT WAS FORWARDED TO MFR. SINCE THE MFR DOES NOT HAVE ANY PREVIOUS KNOWLEDGE OF THIS TYPE OF DEVICE FAILURE, OF THIS EVENT, OR IF THE DEVICE WAS ACTUALLY MANUFACTURED BY W. LORENZ, THEY ARE UNABLE TO SUPPLY ANY ADD'L INFO. SHOULD THEY BECOME AWARE, CO WILL SUBMIT A REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LORENZ SCREW DRIVER TO SCREW TITANIUM PLATES TO FIX THE BONE FLAP HXX * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention| S