BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTERPIECE PLATE FIXATION SYSTEM

    MDR report key: 7288152 · Received February 22, 2018

    Report

    Report Number
    1030489-2018-00257
    Event Type
    Malfunction
    Date Received
    February 22, 2018
    Date of Event
    January 30, 2018
    Report Date
    February 22, 2018
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NQW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT MARKETED IN US BUT A SIMILAR DEVICE WITH CATALOG # 853-465, 510K# K050082 AND UPN (B)(4) IS APPROVED FOR SALE IN US. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE R EPORTED EVENT. X-RAY REVIEW: POST OP X RAY C3-6 LAMINOPLASTY SHOW PLACEMENT OF CENTERPIECE LAMINOPLASTY PLATE. THERE IS BACK OUT OF THE C4 LAMINA SCREW OPPOSITE TO THE FACET SCREW. THIS IS PREDICTABLE FOR LAMINOPLASTY GIVEN FUSION IS NOT EXPECTED TO OCCUR. THE OPERATION IS PROBABLY NOT NECESSARY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH CEREBRAL SPINAL MENINGITIS AND UNDERWENT LAMINOPLASTY AT C3-6. POST-OP, THE X-RAY REPORT REVEALED THE SCREW BACK OUT AT C4 AND C6 ON (B)(6) 2018. NO PATIENT COMPLICATIONS REPORTED AS THE RESULT OF THE EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133702 CENTERPIECE PLATE FIXATION SYSTEM ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL NQW WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1