BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCORDE BUL LOR 9X9X27, 5 DG

    MDR report key: 6453000 · Received April 3, 2017

    Report

    Report Number
    1526439-2017-10224
    Event Type
    Malfunction
    Date Received
    April 3, 2017
    Date of Event
    March 6, 2017
    Report Date
    March 6, 2017
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MAX
    PMA / PMN Number
    K151773
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE (1) VIPER2 ADVANCED ROD HOLDER [PRODUCT CODE: 2867-35-200, LOT NO: 0308MI] WAS RETURNED TO THE CUSTOMER QUALITY UNIT (CQU) FOR EVALUATION. VISUAL EXAMINATION AT THE MACROSCOPIC LEVEL REVEALED AN ASYMMETRIC FRACTURE OF THE ROD HOLDER¿S DISTAL TIP; ONE HALF OF THE TIP HAD FRACTURE WHILE THE OTHER HALF REMAINED INTACT. THE RESULT IS A FRACTURED DISTAL TIP WHICH IS STILL ATTACHED TO THE MAIN BODY OF THE DEVICE. THE FRACTURE ANALYSIS REPORT INDICATED THAT THE FRACTURED SURFACE EXHIBITS ROUGH SURFACE CHARACTERISTICS THAT EXTEND ACROSS THE ENTIRE SURFACE SUGGESTING THAT THE TIP UNDERWENT A STATIC OVERLOAD FAILURE. NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. 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. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. A DEFINITIVE ROOT CAUSE FOR THE ROD HOLDER DISTAL TIP BECOMING FRACTURED CANNOT POSITIVELY BE DETERMINED. HOWEVER, THE FRACTURE ANALYSIS REPORT SUGGESTS THAT THE TIP UNDERWENT A STATIC OVERLOAD FAILURE. 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.

    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.

    Description of Event or Problem · 1

    PHYSICIAN WAS INSERTING ROD ON A T12 FRACTURE FROM T10-L2 AND ROD INSERTER BROKE AT TIP

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236752 CONCORDE BUL LOR 9X9X27, 5 DG INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX DEPUY SYNTHES SPINE 0308MI

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR