BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING NAIL

    MDR report key: 937051 · Received November 2, 2007

    Report

    Report Number
    9610622-2007-00082
    Event Type
    Injury
    Date Received
    November 2, 2007
    Date of Event
    April 9, 2007
    Report Date
    October 26, 2007
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THIS INFO WAS GLEANED FROM AN ARTICLE, NO ADD'L INFO IS AVAILABLE. IT IS NOT KNOWN WHETHER THESE EVENTS WERE PREVIOUSLY REPORTED TO STRYKER AS THE DEVICE, PATIENT AND HOSPITAL INFO IS UNK. IT IS UNK WHICH, IF ANY, OF THE 9 REVISIONS INVOLVED STRYKER IMPLANTS.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED IN AN ARTICLE ("HUMERAL FRACTURES IN THE ELDERLY: TREATMENT WITH A REAMED INTRAMEDULLARY LOCKING NAIL." INJURY, INT. J. CARE INJURED (2007) 38, 945-953, DEPT OF SURGERY, UNIV HOSP. STUDY INCLUDED PEOPLE. THEY HAD ALL RECEIVED TREATMENT WITH A REAMED INTRAMEDULLARY NAIL FOR HUMERAL FRACTURE; SOME WERE OPERATED AFTER A MEAN OF 6 DAYS AND 19 AFTER A MEAN OF 28 DAYS AFTER A PRIMARY DECISION FOR NON OPERATIVE TREATMENT. ON THE BASIS OF THESE RESULTS, WE CONCLUDE THAT TREATMENT OF HUMERAL FRACTURES IN THE ELDERLY WITH A INTRAMEDULLARY NAIL LEADS TO GOOD HEALING AND FUNCTIONAL RESULTS AND AN ACCEPTABLE RE-OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING NAIL IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention