BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL USA SACRAL SCREWS

    MDR report key: 5448005 · Received February 15, 2016

    Report

    Report Number
    MW5060302
    Event Type
    Injury
    Date Received
    February 15, 2016
    Date of Event
    January 26, 2016
    Report Date
    February 1, 2016
    Manufacturer
    SPINAL USA
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    PT HAD SPINAL FUSION L4 TO S1 IN 2013. PT LATER SUSTAINED A FALL. SHE RETURNED TO THE OPERATING ROOM IN (B)(6) 2013 FOR RE-INSTRUMENTATION WITH S1 SCREWS. PER OP REPORT OF (B)(6) 2013, GIVEN THE NEUROLOGIC SYMPTOMS AND KYPHOSIS OF THE SACRUM IT WAS FELT THAT EXPLORATION OF THE FUSION WITH EXTENSION TO THE ILEUM AS WELL AS LAMINECTOMY WAS WARRANTED. PER OP REPORT OF (B)(6) 2013: 8.5 X 80MM ILIAC SCREWS WERE PLACED BILATERALLY. IN (B)(6) 2015, PT CONTINUED TO HAVE LOW BACK PAIN AND RADICULAR SYMPTOMS. PT RETURNED TO OPERATING ROOM ON (B)(6) 2016 FOR REMOVAL OF POSTERIOR SEGMENTAL INSTRUMENTATION AND PARTIAL RESECTION OF RIGHT ILIUM. THE ILIAC SCREWS WERE NOTED TO BE BROKEN. TWO SCREWS HEADS REMOVED. BROKEN PORTIONS IN THE ILEUM WERE LEFT IN PLACE. REF MFR'S #3005739886-2016-00005, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93647 SPINAL USA SACRAL SCREWS SACRAL SCREWS KWP SPINAL USA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention