BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 5823070 · Received July 26, 2016

    Report

    Report Number
    2520274-2016-13657
    Event Type
    Injury
    Date Received
    July 26, 2016
    Report Date
    July 7, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS DATE OF EVENT: LITERATURE CITATION: UZEN, METIN AND ET. AL (2009). ¿LONG-TERM RADIOGRAPHIC COMPLICATIONS FOLLOWING TREATMENT OF UNSTABLE INTERTROCHANTERIC FEMORAL FRACTURES WITH THE PROXIMAL FEMORAL NAIL AND EFFECTS ON FUNCTIONAL RESULTS.¿ ACTA ORTHOP TRAUMATOL TURC 2009 43 (6):457-463 ISTANBUL ARTICLE. THIS REPORT IS FOR UNKNOWN SCREW, UNKNOWN QUANTITY, UNKNOWN LOT FOR PROXIMAL FEMORAL NAIL ANTIROTATION SYSTEM (PFNA) UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, UZEN, METIN AND ET. AL (2009). ¿LONG-TERM RADIOGRAPHIC COMPLICATIONS FOLLOWING TREATMENT OF UNSTABLE INTERTROCHANTERIC FEMORAL FRACTURES WITH THE PROXIMAL FEMORAL NAIL AND EFFECTS ON FUNCTIONAL RESULTS.¿ ACTA ORTHOP TRAUMATOL TURC 2009 43 (6):457-463 ISTANBUL ARTICLE. THE ARTICLE WAS BASED ON A STUDY OF COMPLICATIONS OF 35 PATIENTS (23 WOMEN AND 12 MEN) WHO SUSTAINED UNSTABLE INTERTROCHANTERIC HIP FRACTURES AND WERE TREATED WITH PROXIMAL FEMORAL NAIL ANTIROTATION SYSTEM (PFNA). PATIENTS WERE EVALUATED CLINICALLY AND RADIOGRAPHICALLY AND COMPLICATIONS WERE RECORDED. APPROX 1 PATIENT IDENTIFIED DURING STUDY AS (B)(6) FEMALE WITH CUT-OUT OF SCREW REVISED TO BIPOLAR PROTHESIS. THIS REPORT IS FOR AN UNKNOWN SCREW COMPONENT FOR PROXIMAL FEMORAL NAIL ANTIROTATION SYSTEM (PFNA)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474447 NAIL, FIXATION, BONE JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention