BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 4003892 · Received August 12, 2014

    Report

    Report Number
    2520274-2014-12836
    Event Type
    Injury
    Date Received
    August 12, 2014
    Report Date
    July 22, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. 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. THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING ARTICLE JOURNAL: TWO-STAGE RECONSTRUCTION OF POST-TRAUMATIC SEGMENTAL TIBIA BONE LOSS WITH NAILING. T. APARD, ET AL (2010). ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH 96:549-553. THIS REPORT IS FOR UNKNOWN NAIL/UNKNOWN QUANTITY/UNKNOWN LOT.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING ARTICLE JOURNAL: TWO-STAGE RECONSTRUCTION OF POST-TRAUMATIC SEGMENTAL TIBIA BONE LOSS WITH NAILING. T. APARD, ET AL (2010). ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH 96:549-553. THIS WAS A RETROSPECTIVE STUDY THAT REVIEWED 12 PATIENTS (TEN MALES AND TWO FEMALES) TREATED WITH BONE LOSS USING A SOLID OR LOCKING NAIL (SYNTHES) FOR STATIC FIXATION. MEAN AGE 41 YEARS. ONE PATIENT WAS A 24 YEAR OLD MALE WITH INFECTION. THIS IS REPORT 5 OF 7 FOR (B)(4). THIS REPORT IS FOR 1 UNKNOWN NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479865 NAIL, FIXATION, BONE JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention