BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXP PEEK ROD LRD BA 5.5X75

    MDR report key: 7230365 · Received January 31, 2018

    Report

    Report Number
    1526439-2018-50092
    Event Type
    Injury
    Date Received
    January 31, 2018
    Report Date
    January 17, 2018
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    K073562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DEVICE IS AVAILABLE FOR EVALUATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH THE INVESTIGATION RESULTS. 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

    (B)(4). THE EXP PEEK ROD LRD BA 5.5X75 WAS RETURNED TO THE COMPLAINTS HANDLING UNIT (CHU) FOR EVALUATION. FRACTURE ANALYSIS WAS PERFORMED TO INVESTIGATE THE FRACTURE OF EXP PEEK ROD LRD BA 5.5X75. THE IMAGE EXHIBIT SURFACE MORPHOLOGIES A SMOOTH AND A GRAINY/ROUGH REGION AND PROGRESSION LINES WHICH ARE INDICATIVE OF FATIGUE FAILURE. THIS INDICATES THAT THE FRACTURE FIRST PROPAGATED AND THEN FULL BREAKAGE/FAILURE (ROUGH REGION) TOOK PLACE PRESUMABLY WHEN THE STRENGTH OF THE REMAINING REGIONS DID NOT HAVE THE STRENGTH TO BEAR THE LOADS. FATIGUE STRIATIONS/PROGRESSION LINES ARE ALSO PRESENT IN THE FIGURES THAT EXTEND ACROSS THE SURFACES TOWARD THE POTENTIAL CRACK TERMINATION SITES. A DEVICE HISTORY RECORD REVIEW FOUND NO ISSUES THAT COULD HAVE CAUSE OR CONTRIBUTED TO THE REPORTED EVENT. ALL COMPLAINT TRENDS WILL BE EVALUATED AS A PART OF THE DEPUY SPINE MONTHLY COMPLAINT REVIEW MEETING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE BREAKING OF THE REPORTED PEEK ROD WITH THE INFORMATION PROVIDED. HOWEVER, FRACTURE ANALYSIS SUGGESTS THAT ROD¿S FRACTURED SURFACE SHOW FATIGUE STRIATIONS INDICATIVE OF FATIGUE FAILURE. NO ISSUES WERE IDENTIFIED IN THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. AS SUCH, THIS COMPLAINT WILL BE CLOSED WITHOUT FURTHER ACTION. 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 THE PATIENT UNDERWENT A REVISION ON (B)(6) 2018 DUE TO TWO (2) BROKEN PEEK VIPER RODS. ON AN UNKNOWN DATE, THE PATIENT WAS SLEEPING WHEN THE PEEK RODS SNAPPED AS HE TURNED AND REPORTED PAIN. A MAGNETIC RESONANCE IMAGING (MRI) REVEALED THE RODS WERE SNAPPED/BROKEN AT AN UNKNOWN LEVEL. THE DEVICES (TWO RODS AND AN UNKNOWN AMOUNT OF LOCKING CAPS) WERE REMOVED EASILY AND THE PATIENT WAS REVISED TO A TITANIUM FUSION WITH NEW TITANIUM RODS AND LOCKING CAPS. NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS INITIALLY IMPLANTED WITH HARDWARE AT L4-L6 ON (B)(6) 2017, UNDERWENT A REVISION ON (B)(6) 2017 AND WAS IMPLANTED WITH THE TWO (2) NEW PEEK VIPER RODS. CONCOMITANT DEVICES REPORTED: SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN), LOCKING CAPS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS COMPLAINT IS LINKED WITH (B)(4) FOR THE REVISION WHICH OCCURRED ON (B)(6) 2017. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75144 EXP PEEK ROD LRD BA 5.5X75 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE 5103357

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention