BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG GAMMA AP J NAIL R1.5, RIGHT 10X340 MM X130

    MDR report key: 2070918 · Received April 19, 2011

    Report

    Report Number
    9610622-2011-00172
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    June 1, 2010
    Report Date
    April 5, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT CLEARED FOR SALE IN THE US, BUT A SIMILAR DEVICE IS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THIS CASE IS THE SAME PATIENT AS (B)(6). ON 2007, THE SURGEON USED THE LONG AP-J NAIL IN THE REVISION SURGERY. ON (B)(6) 2010, THE SURGEON FOUND THROUGH THE X-RAY THAT THE LONG AP-J NAIL WAS BROKEN. THE FRACTURE PART OF PATIENT WAS A NON UNION. AFTERWARDS, THE SURGEON WAS MONITORING FOR THE PATIENT. ON (B)(6) 2010, THE PATIENT HAD A PAIN IN THE HIP JOINT. THE SURGEON DID A REVISION SURGERY BY THE BHA ON (B)(6) 2011. THE SURGEON REQUESTED THE INVESTIGATION OF THE BROKEN LONG AP-J NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG GAMMA AP J NAIL R1.5, RIGHT 10X340 MM X130 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K945545

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention