BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLC 6550 POLYAXIAL SCREWS

    MDR report key: 2097461 · Received May 3, 2011

    Report

    Report Number
    3005739886-2011-00001
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 28, 2011
    Manufacturer
    SPINAL USA
    Product Code
    MNI
    PMA / PMN Number
    K090033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSTRUCT CONSISTED OF 4 SLC POLYAXIAL SCREWS, 2 RODS AND 4 CAP SCREWS. ONLY 1 OF THE POLYAXIAL SCREWS WAS RETURNED TO THE MFR FOR EVAL. ALL OTHER HARDWARE WAS KEPT BY THE PT. A VISUAL INSPECTION/EVAL WAS COMPLETED ON THE SCREW THAT WAS RETURNED HOWEVER THE INSPECTION WAS INCONCLUSIVE.

    Description of Event or Problem · 1

    PT HAD A 360 SPINAL FUSION AT L4/L5. PT HAD GRADE 2 SPONDYLOLISTHESIS. F/U X-RAY INDICATED THAT THE POLYAXIAL SCREW HEADS HAD SLIPPED FORWARD AND NOT REMAINED RIGID. PT HAD REVISION SURGERY TO REMOVE THE CONSTRUCT. ONLY 1 OF THE 4 SCREWS WAS RETURNED TO THE MFR FOR EVAL. NONE OF THE RODS OR CAP SCREWS WERE RETURNED TO THE MFR FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLC 6550 POLYAXIAL SCREWS POLYAXIAL SCREW MNI SPINAL USA SLC 6550 2212TS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention