BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIN SCREW DIAM. 2MM LG 14MM

    MDR report key: 2166367 · Received May 22, 2007

    Report

    Report Number
    9615741-2007-00025
    Event Type
    Injury
    Date Received
    May 22, 2007
    Report Date
    May 22, 2007
    Manufacturer
    NEWDEAL S.A.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED ON BEHALF OF THE USER FACILITY THE FOLLOWING INCIDENT: DURING THE SURGERY, THE HEAD OF THE SPIN SCREW BROKE WHILE BEING INSERTED. THE SCREW WAS REMOVED AND IS AVAILABLE FOR EVAL. NO PT INJURY HAD OCCURRED. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIN SCREW DIAM. 2MM LG 14MM FOREFOOT IMPLANT AND INSTRUMENT HWC NEWDEAL S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1