BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMA ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 7800365 · Received August 21, 2018

    Report

    Report Number
    9617297-2018-00009
    Event Type
    Injury
    Date Received
    August 21, 2018
    Date of Event
    July 19, 2018
    Report Date
    August 21, 2018
    Manufacturer
    U&I CORPORATION
    Product Code
    KWQ
    PMA / PMN Number
    K061002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE (B)(4) PLATE ASSEMBLIES HAVE BEEN DISTRIBUTED SINCE 2005, BUT THE SAME EVENT HAS BEEN NEVER REPORTED TO US. THIS IS THE FIRST TIME. THE INCIDENCE OF BREAKAGE OF ELASTIC SUB-PLATE IS (B)(4)%. THE SURGEON SUSPECTS THE PATIENT'S LIFESTYLE AND INADEQUATE MAINTENANCE POSTOPERATIVELY. WE WILL KEEP MONITORING THE PATIENT'S STATUS IN THE FUTURE.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED IN (B)(6). A PATIENT WAS TREATED WITH MAXIMA ANTERIOR CERVICAL PLATE SYSTEM ON (B)(6) 2018. IT WAS FOUND FROM REGULAR INSPECTION THAT ELASTIC SUB-PLATES ON PLATE ASSEMBLY HAVE BEEN BROKEN AND SCREWS HAS BACKED OUT A BIT. THE REVISION SURGERY OR INTERVENTION WAS NOT PERFORMED. THERE WERE NO STRANGE SYMPTOMS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644599 MAXIMA ANTERIOR CERVICAL PLATE SYSTEM SPINAL INTERVERTICAL BODY FIXATION ORTHOSIS KWQ U&I CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other