BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLYAXIAL SCREW-SOLID 5.5X45MM

    MDR report key: 2170213 · Received July 5, 2011

    Report

    Report Number
    3008657535-2011-00026
    Event Type
    Other
    Date Received
    July 5, 2011
    Date of Event
    June 7, 2011
    Report Date
    July 5, 2011
    Manufacturer
    INTERGRA, MEDINA
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT A REVISION SPINAL SURGERY PROCEDURE WAS DONE TO REMOVE SPINAL IMPLANTS. TWO SCREWS AT THE L2 VERTEBRAL LEVEL HAD TORN COLLETS WHICH RESULTED IN THE TULIP SEPARATING FROM THE SCREW SHAFT. AND TWO SCREWS AT VERTEBRAL LEVEL S1 HAD SHEARED OFF HALFWAY DOWN THE SCREW SHAFT, LEAVING A SCREW FRAGMENT IN THE VERTEBRAL BODY. THE SURGEON REPLACED THE S1 SCREWS WHILE LEAVING THE SCREW SHAFT FRAGMENTS IN THE VERTEBRAL BODY. AT L5-S1 INFUSE BONE GRAFT WAS PACKED INTO THE DECORTICATED LATERAL GUTTERS. THE SURGEON REPLACED THE HARDWARE THAT WAS REMOVED. THE SURGEON REPORTED THAT THE INITIAL SURGERY WAS ABOUT A YEAR AGO. THERE WAS A PSEUDARTHROSIS AT L5-S1, WHICH RESULTED IN THE INSTABILITY OF THE CONSTRUCT. IN THE FIRST SURGERY, AN INTERBODY FUSION AT L4-L5, BUT NOT L5-S1 WAS DONE. THE SURGEON WAS FAIRLY CERTAIN THAT THE PT WAS NON-COMPLAINT. THE PT DID NOT FOLLOW POST-OPERATIVE INSTRUCTIONS TO RESTRICT BENDING AND OTHER MOTIONS THAT WOULD RESULT IN A PSEUDARTHROSIS. ALSO, THE PT IS A SMOKER WHICH CONTRIBUTED TO THE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYAXIAL SCREW-SOLID 5.5X45MM CORAL MIS KWP INTERGRA, MEDINA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention