BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R2.0, TI, LEFT GAMMA3 Ø11X320MM X 130°

    MDR report key: 3139803 · Received May 31, 2013

    Report

    Report Number
    0009610622-2013-00301
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A GAMMA NAIL IMPLANTED BY ANOTHER SURGEON AND ULTIMATELY HAD A REMOVAL WITH AND ACCOLADE 2/MDM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242182 LONG NAIL KIT R2.0, TI, LEFT GAMMA3 Ø11X320MM X 130° IMPLANT HSB STRYKER OSTEOSYNTHESIS-KIEL K160891

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention