BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, SPINE, PLATE, LAMINOPLASTY METAL

    MDR report key: 6000341 · Received October 5, 2016

    Report

    Report Number
    2520274-2016-14800
    Event Type
    Injury
    Date Received
    October 5, 2016
    Report Date
    September 8, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    MQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT FOR DIAGNOSIS. YUK, L; ET AL (2016) USE OF MINIPLATES AND LOCAL BONE GRAFTS TO PREVENT SPRING BACK IN LAMINOPLASTY FOR CERVICAL SPONDYLOTIC MYELOPATHY. JOURNAL OF ORTHO, TRAUMA AND REHAB, 20: 24-29. THIS REPORT IS FOR AN UNKNOWN PLATE (UNKNOWN QUANTITY/UNKNOWN LOT). CLASSIFICATION CODE - HQW. (OTHER NUMBER) UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; 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

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: YUK, L; ET AL (2016) USE OF MINIPLATES AND LOCAL BONE GRAFTS TO PREVENT SPRING BACK IN LAMINOPLASTY FOR CERVICAL SPONDYLOTIC MYELOPATHY. JOURNAL OF ORTHO, TRAUMA AND REHAB, 20: 24-29. THIS IS A RETROSPECTIVE STUDY OF 32 CONSECUTIVE PATIENTS WHO UNDERWENT HIRABAYASHI A UNILATERAL OPEN-DOOR LAMINOPLASTY IN UNITED CHRISTIAN HOSPITAL, BETWEEN JUNE 2011 AND JULY 2012. THE DIAGNOSIS OF CERVICAL SPONDYLOTIC MYELOPATHY/OSSIFICATION OF POSTERIOR LONGITUDINAL LIGAMENT WAS MADE CLINICALLY AND RADIOLOGICALLY. THE AIM OF OUR STUDY IS TO LOOK INTO THE CLINICAL AND RADIOLOGICAL OUTCOMES OF THE USE OF MINIPLATES (ARCH PLATES; (B)(4)) AND LOCAL BONE GRAFTS IN CERVICAL LAMINOPLASTY, AS WELL AS TO FIND OUT WHETHER THEY ARE EFFECTIVE IN PREVENTING SPRING BACK. TWENTY-NINE PATIENTS WERE AVAILABLE FOR ANALYSIS BECAUSE TWO DIED OF UNRELATED CAUSES AND ONE WAS A REVISION CASE. NO PATIENTS WERE LOST TO FOLLOW-UP. THE FEMALE-TO-MALE RATIO WAS OF 8:21. THE MEAN AGE WAS 66.6 YEARS AND THE MINIMUM FOLLOW-UP TIME WAS 12 MONTHS. A TOTAL OF 126 LEVELS OF LAMINOPLASTY WERE PERFORMED AND 51 BONE GRAFTS WERE INCORPORATED. THE NUMBER OF BONE GRAFTS USED DEPENDED ON THEIR AVAILABILITY IN THE SPINOUS PROCESSES OF LOWER CERVICAL SPINE. SATISFACTORY DECOM-PRESSION WAS ACHIEVED IN ALL 29 CASES. SIGNS OF BONE UNION WERE DEMONSTRATED IN 123 HINGES AND 51 BONE GRAFTS. NO SPRING BACK WAS DETECTED. POSTOPERATIVELY, THE PATIENTS WERE PUT ON A SOFT NECK COLLAR FOR 8-16 WEEKS. REGULAR FOLLOW-UPS WERE ARRANGED FOR THEM AT THE OUTPATIENT SPINE CLINIC. AT EACH FOLLOW-UP, PATIENTS WERE ASSESSED CLINICALLY FOR ANY UPPER LIMB SYMPTOMS, AXIAL NECK PAIN, C5 PALSY, AND RECURRENCE OF SYMPTOMS. THE CLINICAL OUTCOME IN TERMS OF HIRABAYASHI RECOVERY RATE WAS 47.2%. NO MINIPLATE BREAKAGE OR SCREW LOOSENING WAS FOUND AT 1-YEAR FOLLOW-UP IN ALL PATIENTS. THREE HINGES, EACH ON A DIFFERENT PATIENT, SHOWED HEALING OF ONE CORTEX ONLY. THE THREE PATIENTS SUFFERED FROM AXIAL NECK PAIN. THE SEVERITY OF PAIN WAS MILD, AND THEY WERE ALL TREATED CONSERVATIVELY. TWO PATIENTS DEVELOPED C5 PALSY DURING THEIR FOLLOW-UP. ONE OF THEM IS A RESIDENT OF THE ELDERLY HOME AND SHOWED POOR REHABILITATION POTENTIAL WITH GENERAL DECONDITIONING AFTER THE OPERATION. THE OTHER HAD A SCORE OF 4/17 BEFORE AND 1 YEAR AFTER THE OPERATION. MINIPLATES AND LOCAL BONE GRAFTS ARE PROMISING AND EFFECTIVE TOOLS FOR PREVENTING SPRING BACK IN CERVICAL LAMINOPLASTY. THIS IS 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN ARCH PLATE AND REFERS TO THE SERIOUS INJURY OF 3 UNKNOWN PATIENTS WHO EXPERIENCED AXIAL NECK PAIN AND 2 UNKNOWN PATIENTS WHO EXPERIENCED C5 PALSY, AND 1 UNK PATIENT WHO EXPERIENCED A REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652148 ORTHOSIS, SPINE, PLATE, LAMINOPLASTY METAL MQP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention