BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTERPIECE PLATE FIXATION SYSTEM

    MDR report key: 8762277 · Received July 4, 2019

    Report

    Report Number
    1030489-2019-00708
    Event Type
    Injury
    Date Received
    July 4, 2019
    Report Date
    July 17, 2019
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NQW
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    RADIOLOGICAL IMAGE REVIEW RESULTS: POST-OP X-RAYS FOR CERVICAL LAMINOPLASTY SHOW BACK OUT OF TWO OF THE LUMBAR SCREWS (C4-C6). UNCLEAR AMOUNT OF TIME FROM INITIAL SURGERY. BY REPORT A REVISION SURGERY IS PLANNED. THIS IS A COMMON POSSIBLE FAILURE MODE IN A DEVICE WHERE MOTION PRESERVATION IS FAVORED OVER ARTHRODESIS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: CERVICAL SPONDYLOTIC MYELOPATHY TYPE OF PROCEDURE OR TECHNIQUE USED: LAMINOPLASTY LEVELS IMPLANTED: C4-C6 IT WAS REPORTED THAT POST-OP, THE IMPLANTED BONE SCREW ON THE LAMINA SIDE OF C4-C6 BACKED OUT. THERE WERE NO PATIENT SYMPTOMS OR COM PLICATIONS DUE TO THIS EVENT. REVISION SURGERY WAS SCHEDULED SCHEDULE TO BE DONE. THERE WAS NO DELAY IN OVERALL PROCEDURE DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556437 CENTERPIECE PLATE FIXATION SYSTEM ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL NQW WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention