BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM 5.5 TI SAI POLYAXIAL SCREW

    MDR report key: 4255854 · Received November 17, 2014

    Report

    Report Number
    1526439-2014-12087
    Event Type
    Malfunction
    Date Received
    November 17, 2014
    Report Date
    October 20, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK111571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPEDIUM 8X80MM 5.5 TI POLYAXIAL SCREW (PRODUCT CODE: 1797-06-880, LOT NUMBER: UNKNOWN) WAS RETURNED TO THE COMPLAINTS HANDLING UNIT. THE RETURNED SCREW¿S SADDLE AND SCREW HEAD HAVE BECOME DISLODGED FROM THEIR INTENDED LOCATION AND BECOME STUCK JUST PRIOR TO THE THREADS INSIDE THE TULIP HEAD. ONE PART OF THE TULIP HEAD FEATURES A NUMBER OF SCRATCH MARKS WHICH APPEAR TO HAVE BEEN CAUSED BY THE TOOL USED TO REMOVE THE POLYAXIAL SCREW. THESE SCRATCH MARKS ARE NUMEROUS AND DEEP ENOUGH TO OBSCURE PART OF THE LOT NUMBER ON THE SURFACE OF THE TULIP HEAD. THE REMAINDER OF THE SCREW IS IN GOOD CONDITION. A REVIEW OF THE DHR (DEVICE HISTORY RECORDS) COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. ALTHOUGH THIS POLYAXIAL SCREW WAS RETURNED, THE SURFACE OF THE SCREW THAT FEATURES THE LOT NUMBER IS DAMAGED TO A DEGREE THAT IT IS ILLEGIBLE. A TREND ANALYSIS WAS CONDUCTED ON THE ENTIRE PRODUCT FAMILY AS ALL OF THESE POLYAXIAL SCREWS SHARE THE SAME DIMENSIONS ACROSS THEIR TULIP HEAD, SADDLE, AND SCREW HEAD. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. THE ROOT CAUSE FOR THE HEAD OF THE SCREW DISASSEMBLING CANNOT BE DETERMINED BASED ON THE SAMPLE AND THE INFORMATION PROVIDED. HOWEVER, A PROBABLE ROOT CAUSE MAY HAVE BEEN DUE TO UNANTICIPATED FORCES BEING PLACED ON THE SCREW DURING INSERTION RESULTING IN SADDLE AND SCREW HEAD DISLODGING FROM THEIR INTENDED LOCATION. 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

    IT WAS REPORTED THAT ON (B)(6) 2014, THE SURGEON BEGAN THE 2ND STAGE OF HIS SURGERY. THE SURGEON HAD INSERTED SCREWS AND PERFORMED HIS TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) DURING THE FIRST STAGE WHICH TOOK PLACE ON (B)(6) 2014. ON (B)(6) 2014 HE REOPENED THE WOUND AND PERFORMED OSTEOTOMIES. ONCE COMPLETED, HE REVISITED THE SCREWS AND BEGAN TO MEASURE FOR HIS CORRECTION ROD THROUGH A ROD TEMPLATE. AFTER CUTTING, BENDING A ROD, HE BEGAN TO PLACE THE INNER SET SCREWS, FIXING THE ROD IN THE POLYAXIAL PORTION OF THE HEAD. WHEN HE WENT TO SEAT THE INNER SET SCREW ON THE EXPEDIUM SACRAL ALAR ILIAC (SAI) POLYAXIAL SCREW, HE NOTICED THAT HE WAS HAVING DIFFICULTY CAPTURING THE ROD. DR (B)(6) NOTICED THAT THE SHANK OF THE SAI POLYAXIAL SCREW HAD HAD PUSHED THROUGH THE POLYAXIAL HEAD. HE THEN DECIDED TO REMOVE AND REPLACE THE SAI POLYAXIAL SCREW THAT HAD MALFUNCTIONED. THE DIFFICULTIES RESULTED IN A DELAY TO THE PROCEDURE OF TEN MINUTES WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741346 EXPEDIUM 5.5 TI SAI POLYAXIAL SCREW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1