BEUDAMED
    FDA Adverse Event Injury Summary report: N

    USS-II NUT TAN GREEN

    MDR report key: 3183331 · Received June 21, 2013

    Report

    Report Number
    2530088-2013-00976
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 24, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    KWP
    PMA / PMN Number
    K020517
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE ADDITIONAL INTERNAL VISUAL INSPECTION REVEALED THE THREAD OF SEVERAL SCREWS WERE BADLY DAMAGED. VISIBLE MARKS ON THE SLEEVE AND SCREW HEADS WERE EVIDENT. THIS IS INDICATIVE OF THE SCREW HEAD BEING PUSHED DOWN WITHOUT HAVING THE ROD IN PROPER POSITION. THIS WOULD EXPLAIN THESE VISIBLE DAMAGES. WE WOULD NEED TO HAVE THE INSTRUMENTS BACK IN ORDER TO CONDUCT A MORE DETAILED INVESTIGATION. NO PRODUCT FAULT COULD BE DETECTED. THE COMPLAINT WAS DETERMINED TO BE INDETERMINATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: USS II NUTS WOULD NOT CLOSE THE SCREWS. THE SLEEVES DID NOT EMBRACE THE SCREWS UNTIL THE END OF THE SCREW HEAD. THE PERSUADER INSTRUMENT DID NOT HELP THE PROCEDURE. IT WAS HARD TO PUT IN THE SLEEVES BUT AFTER ALL THE SCREWS WERE REALIGNED AND PULLED OUT A LITTLE FROM THE PEDICLE, THE SURGEON WAS ABLE TO PUSH DOWN THE SLEEVES BUT THE NUTS DID NOT FIT IN. AFTER THREE HOURS TRYING TO CLOSE THE SCREWS THE SURGEON DECIDED TO TAKE OUT ALL THE 20 USS II SCREWS INSERTED AND CHANGE THEM FOR USS I SCREWS. AFTER USS I INSERTION, THE SURGEON CLOSED THE SYSTEM AND FINISHED THE SURGERY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283588 USS-II NUT TAN GREEN APPLIANCE, FIXATION, SPINAL KWP SYNTHES BRANDYWINE 8252756

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention