BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, BONE

    MDR report key: 4163576 · Received October 10, 2014

    Report

    Report Number
    2520274-2014-14081
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR ONE UNKNOWN ROD/UNKNOWN LOT NUMBER. IMPLANT DATE 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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EXPLANT SURGERY, DUE TO PATIENT PAIN, THE SLAP HAMMER LOCKED UP AND WAS UNABLE TO BE USED WHEN ATTEMPTING TO EXTRACT THE RETROGRADE ROD (THERE WAS SIGNIFICANT BONE GROWTH AROUND THE ROD). THE EXTRACTION SCREW WAS UNABLE TO BE THREADED INTO THE ROD. A SECOND EXTRACTION SCREW HAD TO BE USED TO COMPLETE THE PROCEDURE. TWO DISTAL SCREWS AND ONE PROXIMAL SCREW WERE REMOVED ALONG WITH THE RETROGRADE ROD. HARDWARE WAS ALL INTACT. THERE WAS NO DELAY TO SURGERY. THIS REPORT IS FOR AN UNKNOWN ROD. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639682 ROD, FIXATION, BONE HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention