BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT - LOCKING SCREW

    MDR report key: 1791781 · Received August 4, 2010

    Report

    Report Number
    9610622-2010-00327
    Event Type
    Injury
    Date Received
    August 4, 2010
    Date of Event
    May 21, 2010
    Report Date
    July 19, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA THE SALES REP THAT THE DISTAL LOCKING SCREW BROKE, BUT THE NAIL REMAINED COMPLETE. FURTHER INFORMATION HAS BEEN REQUESTED FROM THE SALES REP. PATIENT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT - LOCKING SCREW IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention