BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM ROD, 120MM

    MDR report key: 3926446 · Received July 10, 2014

    Report

    Report Number
    1526439-2014-11669
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 16, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK033901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    A TOTAL OF TWENTY TWO DEVICES ¿ 2 EXPEDIUM RODS, 7 VIPER SINGLE SET SCREWS, 3 EXPEDIUM SINGLE INNER SET SCREWS, AND 8 VIPER POLYAXIAL SCREWS - WERE RETURNED AFTER THE COMPLAINT HAD BEEN CLOSED. THE DEVICES WERE RETURNED WITH SIGNS OF USAGE BUT DO NOT FEATURE ANY DEFECTS THAT WOULD AFFECT THEIR PERFORMANCE. IT WAS NOTED THAT THERE WERE TWO POLYAXIAL SCREWS FEATURED A SADDLE THAT HAD BEEN PARTIALLY DISLODGED TO THE POINT OF BEING MISALIGNED WITH THE SWAGING HOLE. THE REMAINING POLYAXIAL SCREWS AND THE TWO RODS FEATURED NO OTHER DAMAGE BEYOND THAT WHICH WOULD BE EXPECTED THROUGH WEAR DURING USE. THE SADDLES MOST LIKELY BECAME DISLODGED DURING REMOVAL AS THE POSITION OF THE SADDLES WOULD NOT BE POSSIBLE WITH THE ROD PROPERLY INSERTED INTO THE POLYAXIAL SCREWS¿ TULIP HEADS. THREE OF THE TEN RETURNED SETS SCREWS DID NOT FEATURE NORMAL WITNESS MARKS WHICH MAY INDICATE THAT FINAL TIGHTENING DID NOT PROPERLY OCCUR ON THE MAJORITY OF THE RETURNED SET SCREWS, PERMITTING THE ROD TO SLIDE. A REVIEW OF COMPLAINT TRENDS FOR SINGLE INNER SET SCREWS AND RODS FOUND NO EMERGING TRENDS. A ROOT CAUSE CANNOT BE DETERMINED FROM THE RETURNED SAMPLES AND THE INFORMATION PROVIDED. THE MOST PROBABLE ROOT CAUSE IS LACK OF FINAL TIGHTENING OF THE SET SCREWS ALLOWED THE ROD TO SLIDE. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS NECESSARY AT THIS TIME AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURE OR RELEASE OF THESE PARTS. THEREFORE, THIS COMPLAINT 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

    THE VIPER2 STRAIGHT ROD WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DISCREPANCIES WERE OBSERVED DURING THE MANUFACTURING PROCESS OF EITHER PART. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THE PRODUCT LOT THAT COULD CONTRIBUTE TO THE PROBLEM REPORTED BY THE CUSTOMER. THE LOT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A 12 MONTH REVIEW OF THE COMPLAINT TREND ANALYSIS WAS PERFORMED ON THE PRODUCT FAMILY AS THE ONLY DIFFERENCE BETWEEN THESE RODS IS THEIR LENGTH AND TIP TYPE, WHICH WOULD NOT AFFECT THE SET SCREWS¿ ABILITY TO HOLD THE RODS IN PLACE. THERE WERE ZERO (0) RELATED COMPLAINTS ASSOCIATED WITH THE SET SCREW BEING UNABLE TO HOLD THE ROD IN PLACE. NO SYSTEMIC COMPLAINT TREND WAS IDENTIFIED THAT WOULD REQUIRE FURTHER ACTION. WITHOUT THE PRODUCT, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. NO CORRECTIVE AND PREVENTIVE ACTION IS NECESSARY AT THIS TIME AS WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE. THEREFORE, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF THE COMPLAINT PRODUCT SAMPLE BECOMES AVAILABLE, THE COMPLAINT WILL BE REOPENED AND THE PRODUCT WILL BE EVALUATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. NOT RETURNED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS A VIPER2 STRAIGHT ROD SLID/MOVED IN SITU EVEN THOUGH THE SCREWS OF THE CONSTRUCT WERE FIXED IN PLACE AND THE POLYAXIALITY OF THE SCREWS WAS MAINTAINED. THE MIS SINGLE INNER SET SCREW, VIPER2 STRAIGHT ROD, AND CONCOMITANT DEVICE MIS CANNULATED POLYAXIAL SCREW WERE REMOVED AND REPLACED DURING REVISION SURGERY. THE CAUSE OF ROD SLIPPAGE/PULLOUT IS UNKNOWN AS IT MAY HAVE BEEN DUE TO LOOSENING OF THE SET SCREW OR PULLING OF ROD. AS THE CONDITION HAS RESULTED IN THE NEED FOR SURGICAL INTERVENTION/REVISION SURGERY, THE FOLLOWING MFG. MEDWATCH REPORTS ARE BEING FILED FOR THE MIS SINGLE INNER SET SCREW AND VIPER2 STRAIGHT ROD THAT WERE INVOLVED IN THE EVENT: 1526439-2014-11668, 1526439-2014-11669.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE HAD REPORTED THAT VIPER2 STRAIGHT ROD SLID/MOVED IN SITU EVEN THOUGH THE SCREWS OF THE CONSTRUCT WERE FIXED IN PLACE AND THE POLYAXIALITY OF THE SCREWS WAS MAINTAINED. MFG. MEDWATCH REPORTS 1526439-2014-11668 AND 1526439-2014-11669 WERE SUBMITTED FOR THE MIS SINGLE INNER SET SCREW AND THE VIPER2 STRAIGHT ROD THAT WERE REPORTED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. ON (B)(6) 2014, THE ENTIRE CONSTRUCT WAS RETURNED TO DEPUY SYNTHES SPINE FOR EVALUATION, INCLUDING 2 EXPEDIUM RODS, 7 VIPER SINGLE INNER SET SCREWS, 3 EXPEDIUM SINGLE INNER SET SCREWS, AND 8 VIPER POLYAXIAL SCREWS. ACCORDING TO THE AFFILIATE, THE ORIGINAL PRODUCTS THAT WERE REPORTED ON WERE INCORRECT AND THEY ASKED THAT THE RETURNED DEVICES BE INVESTIGATED. FROM THE RETURNED DEVICES, IT IS NOT KNOWN WHICH VIPER2 STRAIGHT ROD, SINGLE INNER SET SCREW AND CONCOMITANT DEVICE POLYAXIAL SCREW WERE INVOLVED IN THE REPORTABLE THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405062 EXPEDIUM ROD, 120MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MIS CANNULATED POLY SCREW, 186715740