BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-06058

    MDR report key: 3330323 · Received September 6, 2013

    Report

    Report Number
    2520274-2013-06058
    Event Type
    Injury
    Date Received
    September 6, 2013
    Report Date
    August 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: 2002. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    A JOURNAL ABSTRACT RECEIVED ENTITLED: INTERNAL FIXATION OF TROCHANTERIC FRACTURES BY PROXIMAL FEMORAL NAIL. DOUSA P., BARTONICEK J., JEHLICKA D., SKALA-ROSENBAUM J. ACTA CHIRURGIAE ORTHOPAEDICAE ET TRAUMATOLOGIAE CECHOSLOVACA. 2002 ; 69 (1) :22-30. A PROSPECTIVE STUDY EVALUATING A GROUP OF 41 PATIENTS, 12 MEN AND 29 WOMEN, AVERAGE AGE 68 YEARS OPERATED ON BETWEEN SEPTEMBER 1997 AND MARCH 2001 BY MEANS OF PROXIMAL FEMORAL NAIL FIXATION. THE GROUP WAS COMPRISED OF 11 UNSTABLE PERITROCHANTERIC FRACTURES, 26 HIGH SUBTROCHANTERIC FRACTURES, 3 LOW SUBTROCHANTERIC FRACTURES AND 1 PATHOLOGICAL FRACTURE. THIS COMPLAINT REGARDS A PATIENT THAT EXPERIENCED FAILED DISTAL FIXATION OF THE NAIL. THE FRACTURES HEALED. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN DISTAL SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443069 HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention