BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPRACONDYLAR NAIL T2 SCN 10 X 200 MM

    MDR report key: 2664928 · Received July 17, 2012

    Report

    Report Number
    9610622-2012-00307
    Event Type
    Injury
    Date Received
    July 17, 2012
    Date of Event
    June 25, 2012
    Report Date
    June 25, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS ¿ KIEL
    Product Code
    HSB
    PMA / PMN Number
    K023267
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ASSOCIATED DEVICES: (B)(4) LOCKING SCREW, FULLY THREADED T2 TIBIA 5 X 65 MM, K982447; (B)(4) LOCKING SCREW, FULLY THREADED T2 TIBIA 5 X 35 MM, K90934; (B)(4) LOCKING SCREW, FULLY THREADED T2 TIBIA 5 X 35 MM, K613673; (B)(4) LOCKING SCREW, FULLY THREADED T2 TIBIA 5 X 85 MM KK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, COMPOUND OPEN FEMUR FRACTURE FROM MOTORCROSS ACCIDENT. HE CAME BACK TO DR AND COMPLAINED OF A POP SOUND. DR X-RAYED THE PT'S LEG WHICH WAS NEGATIVE. ON (B)(6), A REPEAT X-RAY WAS DONE AND SHOWED A BROKEN NAIL. I HAVE INCLUDED OP REPORTS FROM 1ST CASE AND 2ND CASE. ALSO ALL IMPLANT STICKERS. ALSO FILMS 1ST CASE, 2ND CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPRACONDYLAR NAIL T2 SCN 10 X 200 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS ¿ KIEL NA K478332

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention