BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    MDR report key: 9793405 · Received March 5, 2020

    Report

    Report Number
    1030489-2020-00260
    Event Type
    Injury
    Date Received
    March 5, 2020
    Report Date
    March 5, 2020
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE TITLE: "MOTION PRESERVATION AT ALL COSTS? MULTILEVEL HINGE NONUNION, PLATE BREAKAGE, AND INTRADURAL PLATE MIGRATION AFTER CERVICAL LAMINOPLASTY: A CASE REPORT AND LITERATURE REVIEW" AUTHORS: ALEXANDER ROSINSKI, KHALID ODEH, JEREMI LEASURE, DIMITRIY KONDRASHOV CITATION: WORLD NEUROSURG. (2020) 135:80-86. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE ABSTRACT THAT THE PATIENT WITH A HISTORY OF CERVICAL SPONDYLOTIC MYELOPATHY; AND UNDERWENT C3-C7 OPEN-DOOR CERVICAL LAMINOPLASTY. ON AN UNKNOWN DATE, POST THE SURGERY, PATIENT SUFFERED WITH SEVERE, INTRACTABLE HEADACHES OF 1 MONTH DURATION. HE ALSO REPORTED ELECTRICAL-TYPE PAIN THROUGH THE LEFT ARM, BUTTOCK, AND THIGH. ON PHYSICAL EXAMINATION, THERE WAS SLIGHT HYPER-REFLEXIA IN BOTH UPPER EXTREMITIES. HIS LEFT STRAIGHT LEG RAISE REPRODUCED A LHERMITTE'S TYPE SIGN, WITH ELECTRICITY RUNNING THROUGH THE LEFT SIDE OF HIS ENTIRE BODY. THE REMAINDER OF HIS EXAMINATION WAS UNREMARKABLE. COMPUTED TOMOGRAPHY SCAN OF THE CERVICAL SPINE SHOWED SEVERAL BROKEN LAMINOPLASTY PLATES (C4, C6, AND C7), INCLUDING INTRADURAL MIGRATION OF A FRAGMENT OF THE C7 PLATE. THE SEVERE HEADACHES WERE ATTRIBUTED TO LOCAL DAMAGE FROM THE PLATE FRAGMENTS AND BLOOD WITHIN THE SUBARACHNOID SPACE AND POSSIBLE CSF LEAKAGE. THERE WAS ALSO HINGE NONUNION AT C5, C6, AND C7. THE PATIENT CONSENTED TO URGENT SPINAL DECOMPRESSION AND REVISION LAMINECTOMY AND FUSION. HENCE, A STANDARD POSTERIOR APPROACH TO THE SUBAXIAL SPINE WAS PERFORMED. PLATE BREAKAGE WAS CONFIRMED AT C4, C6, AND C7. EACH OF THESE LAMINOPLASTY PLATES WAS BROKEN IN MORE THAN 2 PIECES. STABLE HINGE UNION WAS OBSERVED ON THE RIGHT SIDE AT C3 AND C4. THERE WAS A 7-MM DURAL DEFECT AND CSF LEAKAGE AT THE MEDIAL EDGE OF THE C7 LATERAL MASS. A FRAGMENT OF THE C7 PLATE WAS FOUND IN THE DORSAL PART OF THE DURA IMMEDIATELY ADJACENT TO THE SPINAL CORD ALONG WITH A DURAL DEFECT. EACH LAMINOPLASTY PLATE WAS CAREFULLY REMOVED, AND THE DURA WAS REPAIRED WITH A DURAL PATCH AND SEALANT BECAUSE IT WAS NOT AMENABLE TO PRIMARY REPAIR. LAMINECTOMY AND FUSION WERE THEN PERFORMED AT C5-C7. THE PATIENT'S POSTOPERATIVE COURSE WAS UNEVENTFUL. HIS HEADACHES AND LEFT-SIDED SHOOTING PAIN HAVE RESOLVED COMPLETELY. AT LATEST FOLLOW-UP, HE HAD SOME RESIDUAL NECK PAIN WHEN ROTATING HIS HEAD TO THE LEFT BUT WAS OTHERWISE ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255797 APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention