BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAG SCREW, TI 10.5 X 90MM

    MDR report key: 1252818 · Received December 4, 2008

    Report

    Report Number
    9610622-2008-00253
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    October 31, 2008
    Report Date
    October 31, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HWC
    PMA / PMN Number
    K034002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND IF REC'D, WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED PT UNDERWENT SURGERY WITH A G3 NAIL. IN 2008, THE SURGEON FOUND THROUGH X-RAY THAT THE LAG SCREW HAD SLID MORE THAN NECESSARY. THE SURGEON REVISED THE LAG SCREW TO A SHORT SIZED LAG SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAG SCREW, TI 10.5 X 90MM IMPLANT HWC STRYKER OSTEOSYNTHESIS KIEL NA K974996

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention