BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, SPINE, PLATE,

    MDR report key: 6085128 · Received November 8, 2016

    Report

    Report Number
    2520274-2016-15270
    Event Type
    Injury
    Date Received
    November 8, 2016
    Date of Event
    November 25, 2012
    Report Date
    October 28, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    MNI
    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. THIS REPORT IS FOR AN UNKNOWN MINIPLATE (UNKNOWN QUANTITY/UNKNOWN LOT). PRODUCT CODE NQW. (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 THE SUBSEQUENT REVIEW OF THE FOLLOWING ARTICLE: CHEN, Y; ET AL (2013) SIGNIFICANCE OF SEGMENTAL INSTABILITY IN CERVICAL OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT AND TREATED BY A POSTERIOR HYBRID TECHNIQUE. ARCH ORTHOP TRAUMA SURG, 133:171-177 THIS IS A RETROSPECTIVE COHORT CASE STUDY TO EVALUATE THE SIGNIFICANCE OF SEGMENTAL INSTABILITY (SI) IN CERVICAL OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT (OPPL) MYELOPATHY AND EFFECTIVENESS OF A POSTERIOR HYBRID TECHNIQUE IN THE TREATMENT OF OPLL ASSOCIATED WITH SI. BETWEEN MAY 2005 AND AUGUST 2007, 15 PATIENTS WITH MULTILEVEL CERVICAL OPLL, DIAGNOSED TO BE ASSOCIATED WITH SI, WERE TREATED BY A POSTERIOR HYBRID TECHNIQUE INCLUDING LAMINOPLASTY AND FUSION AT INSTABLE LEVELS WITH LATERAL MASS SCREW FIXATION. ANOTHER 15 COHORT PATIENTS WITHOUT SI TREATED BY LAMINOPLASTY IN THE SAME PERIOD WERE INCLUDED IN THE CONTROL GROUP. UNILATERAL OPEN-DOOR LAMINOPLASTY WITH TITANIUM ARCH MINIPLATES (SYNTHES, (B)(4)) WAS PERFORMED TO TREAT ALL PATIENTS, NO MATTER WHO WERE WITH OR WITHOUT SI. FIVE PATIENTS ASSOCIATED WITH SI, IN ADDITION TO THE LAMINOPLASTY HAD LATERAL MASS SCREW FIXATION (MEDTRONIC SOFAMOR DANEK, USA). EACH GROUP HAD 1 PATIENT WHO DEVELOPED UNILATERAL C5 PALSY ON THE OPEN DOOR SIDE OF LAMINOPLASTY; TREATED WITH NEUROTROPHY DRUGS, HYPERBARIC OXYGEN THERAPY AND FUNCTIONAL EXERCISES. THREE CASES OF LATE NEUROLOGICAL DETERIORATION WERE OBSERVED IN THE OPLL WITHOUT SI GROUP. AT THE 4 YEAR FOLLOW-UP POINT, 4 CASES OF POSTOPERATIVE KYPHOTIC CHANGES OF THE CERVICAL SPINE AND 2 CASES OF POSTOPERATIVE PROGRESSION OF THE OSSIFIED LESION WERE OBSERVED IN THE OPLL WITHOUT SI GROUP. SEGMENTAL INSTABILITY, A DEGENERATIVE DYNAMIC FACTOR IS IMPORTANT TO THE OPLL MYELOPATHY. THE POSTERIOR HYBRID TECHNIQUE SEEMED TO BE EFFECTIVE AND SAFE IN THE TREATMENT OF SELECTIVE OPLL PATIENTS ASSOCIATED WITH SI. THE BENEFITS MAY INCLUDE PROVIDING STABILIZATION ENVIRONMENT FOR SPINAL CORD RECOVERY AND PREVENTING PROGRESSIVE KYPHOTIC CHANGE AND PROGRESSION OF OPLL. THIS REPORT IS 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN MINIPLATES AND REFERS TO THE SERIOUS INJURY OF UNKNOWN PATIENTS WHO EXPERIENCED DEVELOPED C5 PALSY, LATE NEUROLOGICAL DETERIORATION AND PROGRESSION OF OSSIFIED LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738151 ORTHOSIS, SPINE, PLATE, MNI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention