BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-01435

    MDR report key: 3001388 · Received March 13, 2013

    Report

    Report Number
    2520274-2013-01435
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS INITIALLY IMPLANTED WITH EIGHT (8) UNIVERSAL REDUCTION SCREWS (URS) AND TWO (2) NFLEX RODS ON AN UNKNOWN DATE. PATIENT WAS RETURNED TO THE OR IN (B)(6) 2012 (DATE UNKNOWN) FOR THE FIRST REVISION SURGERY DUE TO PERSISTENT PAIN. IN (B)(6) 2012, THE PATIENT WAS REVISED WITH 2 CAGES, PLIF AND THE NFLEX RODS WERE REPLACED WITH USS RODS. PATIENT WAS THEN RETURNED TO THE OR ON (B)(6) 2013 FOR A SECOND REVISION. REPORTEDLY THE USS RODS CAME OUT FROM THE SCREWS AND THERE WAS AN INCORRECT FIXATION. THE INTERNAL PARTS OF THE LOCKING NUT WERE NOT LOCKED AND THE RODS WERE FREE TO SLIDE. IT WAS REPORTED THE PATIENT IS OKAY. THIS REPORT IS FOR THE 2ND REVISION ON THE UNKNOWN PEDICLE SCREW. THIS IS 3 OF 4 REPORTS FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THIS IS 3 OF 4 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105785 NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention