BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXP 5.5 TI SAI POLY 8X80MM

    MDR report key: 5822154 · Received July 26, 2016

    Report

    Report Number
    1526439-2016-10537
    Event Type
    Malfunction
    Date Received
    July 26, 2016
    Date of Event
    June 29, 2016
    Report Date
    June 29, 2016
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    K111571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: DEVICE EVALUATED BY MFR? ADDITIONAL INFORMATION: DEVICE MANUFACTURE DATE, EVALUATION CODES. (B)(4). THE EXPEDIUM 5.5 TI SAI 8X80MM POLYAXIAL SCREW (PRODUCT CODE: 1797-04-880, LOT NUMBER: TBIXT) WAS RETURNED TO THE COMPLAINTS HANDLING UNIT (CHU) ON JULY 22ND, 2016. THE BODY OF THE SCREW DOES NOT FEATURE ANY OBSERVABLE DAMAGE. HOWEVER, THE TULIP HEAD¿S THREADS HAVE ALL BEEN TORN OFF, LEAVING ROUGH, ROUNDED EDGES WHERE THE THREADS SHOULD BE. NO OTHER DAMAGE WAS FOUND. THIS DAMAGE MAY HAVE OCCURRED IF AN ASSOCIATED SET SCREW WAS CROSS THREADED DURING INSERTION. TIGHTENING A SET SCREW WHILE IT IS CROSS THREADED PLACES AN UNEXPECTEDLY HIGH AMOUNT OF FORCE ON THE THREADS OF BOTH THE SET SCREW AND TULIP HEAD, POTENTIALLY RESULTING IN THE THREADS BEING DAMAGED OR TORN. DHR REVIEW IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. THE ROOT CAUSE OF THE THREADS INSIDE THE TULIP HEAD TEARING CANNOT BE DETERMINED FROM THE SAMPLE AND THE INFORMATION PROVIDED. A POTENTIAL ROOT CAUSE MAY BE INADVERTENTLY CROSS THREADING THE SET SCREW DURING INSERTION, LEADING TO THE THREADS TEARING DURING AN ATTEMPT TO TIGHTEN THE SET SCREW. 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 REQUIRING IMMEDIATE ACTION HAVE BEEN OBSERVED, 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.

    Description of Event or Problem · 1

    A SURGERY FOR LUMBAR SPINAL CANAL STENOSIS WAS PERFORMED ON (B)(6) 2016 TO IMPLANT CANNULATED SAI POLYAXIAL SCREWS INTO THE PATIENT'S L2-SAI. IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO INSERT A SET SCREW INTO THE HEAD OF THE REPORTED SAI SCREW. THE SET SCREW WAS REPLACED WITH ANOTHER ONE, BUT TO NO AVAIL. IT WAS CONCLUDED THAT THERE WAS A PROBLEM WITH THE REPORTED SCREW, THUS IT WAS REPLACED WITH A NEW ONE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES, BUT DUE TO THE EVENT THERE WAS 30 MINUTES SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SURGEON NOTED THAT THE HEAD OF THE REPORTED SCREW MIGHT HAVE GOT CROSS-THREADED AND DAMAGED WHEN THE SURGEON WAS FORCING THE SET SCREW INTO IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476268 EXP 5.5 TI SAI POLY 8X80MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE TBIXT

    Patients

    Seq Age Sex Outcome Treatment
    1