BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.7MM CABLE WITH CRIMP 750MM-STERILE

    MDR report key: 4760187 · Received May 8, 2015

    Report

    Report Number
    2520274-2015-13723
    Event Type
    Injury
    Date Received
    May 8, 2015
    Report Date
    April 20, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    JDQ
    PMA / PMN Number
    PK992616
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WEIGHT UNKNOWN. EVENT DATE: UNKNOWN. IMPLANT DATE NOT REPORTED, UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY WITH BONE GRAFTING ON (B)(6) 2015 DUE TO A NON-UNION OF THE RIGHT FEMUR. THE ORIGINAL SURGERY WAS AN OPEN REDUCTION PERI-PROSTHETIC FOR A RIGHT FEMUR FRACTURE ON AN UNKNOWN DATE. FRACTURE WENT ON TO A NON-UNION AND WAS REVISED. ALL HARDWARE WAS REMOVED, BONE GRAFT WAS INSERTED, A NEW 16 HOLE CURVED PERI-PROSTHETIC PLATE WAS IMPLANTED, SECURED WITH CABLES AND SCREWS. ALL PREVIOUS HARDWARE WAS NOTED TO BE INTACT. NO FURTHER COMPLICATIONS NOTED, PATIENT OUTCOME WAS STABLE AND NO DELAY IN SURGERY. CONFIRMED, THERE IS NO ADDITIONAL INFORMATION AND NO PARTS WILL BE RETURNED. THIS REPORT IS 14 OF 17 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303764 1.7MM CABLE WITH CRIMP 750MM-STERILE CERCLAGE FIXATION JDQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention