BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IEXP 55 TI TWISTER

    MDR report key: 4669622 · Received April 8, 2015

    Report

    Report Number
    1526439-2015-10263
    Event Type
    Malfunction
    Date Received
    April 8, 2015
    Date of Event
    March 13, 2015
    Report Date
    March 13, 2015
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK101070
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON INITIAL MW-212492 IS INCORRECT AND SHOULD BE (B)(6) 2015. 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

    THE TWO (2) IEXP 55 TI TWISTERS (PRODUCT CODE: 1754-55-030, LOT NUMBER: T6624) WERE RETURNED TO THE COMPLAINTS HANDLING UNIT (CHU) ON APRIL 6TH, 2015. VISUAL EXAMINATION REVEALED THAT THERE ARE NO MARKINGS, SCRATCHES, OR OTHER SIGNS OF DAMAGE ON THE SURFACE OF THE TWISTERS. IT WAS NOTED THAT THE TWISTERS COULD BE FORCEFULLY REASSEMBLED AND COULD FUNCTION NORMALLY AFTERWARDS A TREND ANALYSIS WAS CONDUCTED. NO FURTHER ACTIONS FROM TRENDING ANALYSIS ARE REQUIRED. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE ROOT CAUSE FOR THE TWISTERS DISASSEMBLING CANNOT BE DETERMINED FROM THE SAMPLES AND THE INFORMATION AVAILABLE. A POTENTIAL ROOT CAUSE IS UNEXPECTEDLY HIGH FORCES APPLIED TO THE TWISTERS DURING USE, RESULTING IN THE IN TWO PARTS OF THE TWISTER DISASSEMBLING. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS WERE FOUND, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. 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

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. 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

    IMPLANT FAILURE IN OUR OFFSET EXPEDIUM DEFORMITY CORRECTION CASE TODAY IN (B)(6). TWO OF THE BELOW IMPLANTS CAME APART DURING THE CASE. (B)(4) TWISTER BOTH IMPLANTS ARE BEING PROCESSED AND SHOULD BE READY FOR COLLECTION ON MONDAY. SAME LIKE PRODUCT USED TO COMPLETE THE CASE. SURGERY DELAYED BY 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231587 IEXP 55 TI TWISTER ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1