BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI NUT 11MM WIDTH ACROSS FLATS

    MDR report key: 3800551 · Received May 8, 2014

    Report

    Report Number
    1000562954-2014-10074
    Event Type
    Injury
    Date Received
    May 8, 2014
    Report Date
    April 4, 2014
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    KWP
    PMA / PMN Number
    PK141897
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. AS PER RECEIVED CONDITION OF DEVICE; THE NUT HAS BEEN RECEIVED IN INTACT CONDITION (VISUAL EXAMINATION). THE COMPLAINT IS UNCONFIRMED ADDITIONAL PRODUCT CODES: MNH, MNI. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT SUFFERED AN INFECTION APPROXIMATELY SEVEN MONTHS AFTER THE INITIAL SURGERY. THE PATIENT WAS REVISED AND ANOTHER UNIVERSAL SPINE SYSTEM VARIABLE AXIS SCREW SET WAS USED FOR RE-INSTRUMENTATION. THERE IS NO REPORT OF DELAY IN SURGERY OR OTHER ADDITIONAL INTERVENTION. THIS IS REPORT 8 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278449 TI NUT 11MM WIDTH ACROSS FLATS APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP SYNTHES MEZZOVICO 7721749

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention