BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL NAIL, A/R 10X340 MM

    MDR report key: 1931541 · Received December 9, 2010

    Report

    Report Number
    9610622-2010-00526
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 26, 2010
    Report Date
    November 26, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K021026
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE MALAYSIA DEALER REPORTED A BROKEN IMPLANT (S2 NAIL) INCIDENT AT (B)(6). THE PT WAS IMPLANTED IN (B)(6) 2010. THE NAIL WAS FOUND TO BE BROKEN. THE PT WAS REVISED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL NAIL, A/R 10X340 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K225529R

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention