BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREW

    MDR report key: 32918 · Received May 9, 1996

    Report

    Report Number
    MW1009057
    Event Type
    Malfunction
    Date Received
    May 9, 1996
    Date of Event
    April 30, 1996
    Report Date
    May 1, 1996
    Manufacturer
    OSTEOMED CORP.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    12 MM SCREW BROKE OFF IN SKULL AT 6 MM; 1/2 MM OUT OF SKIN AND 5 MM INTO SKULL WHILE BEING SCREWED IN. STUMP LEFT IN COULDN'T GET OUT. A 2ND SCREW 3 MM BEHIND IT HAD TO BE PLACED. PROCEDURE WAS AS FOLLOWS - ENDOSCOPIC BROW LIFT WITH BILATERAL PTOSIS REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE SCREW Implant BONE SCREW HWC OSTEOMED CORP. 952312

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other