BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, SPINAL PEDICLE FIXATION

    MDR report key: 4141480 · Received October 4, 2014

    Report

    Report Number
    2520274-2014-13902
    Event Type
    Injury
    Date Received
    October 4, 2014
    Report Date
    September 8, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    MNI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. CORRECTED FROM ADVERSE EVENT AND PRODUCT PROBLEM TO ADVERSE EVENT. THERE IS NO REPORT OF A PRODUCT MALFUNCTION; HOWEVER, THIS DEVICE CANNOT BE DISASSOCIATED FROM THE REPORTED ADVERSE EVENT. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR ONE UNKNOWN UNIVERSAL SPINAL SYSTEM. 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. 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¿S ORIGINAL SURGERY WAS A L2-L4 FUSION WITH A SYNTHES UNIVERSAL SPINAL SYSTEM (USS) ON AN UNKNOWN DATE. THE USS SYSTEM WAS OVERGROWN WITH SCAR TISSUE AND BONE AND THE PATIENT HAD A NON-UNION. DURING THE REVISION SURGERY, TWO SCREWDRIVERS STRIPPED WHILE TRYING TO REMOVE THE IMPLANTED SCREWS THAT WERE PREVIOUSLY PLACED WITH A (USS) INSTRUMENTATION. THERE WAS A BACKUP SCREWDRIVER AVAILABLE. HOWEVER, THIS ONE WAS ALSO STRIPPED DURING USE. BUT, SURGEON WAS ABLE TO REMOVE THE SCREWS WITH THE SECOND SCREWDRIVER AND SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT AND NO REPORTS OF A TIME DELAY. THIS REPORT IS FOR ONE UNKNOWN UNIVERSAL SPINAL SYSTEM. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621586 ORTHOSIS, SPINAL PEDICLE FIXATION MNI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention