BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACC HEX ROD 5.5X480MM, SS

    MDR report key: 3122784 · Received May 21, 2013

    Report

    Report Number
    1526439-2013-17389
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    April 29, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    KWP
    PMA / PMN Number
    P1
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED ROD AT THE MACROSCOPIC LEVEL CONFIRMED ROD BREAKAGE WHICH RESULTED IN TWO ROD SEGMENTS. SCANNING ELECTRON MICROSCOPY ANALYSIS FOUND THE FRACTURED SURFACES EXHIBITED SMOOTH AND GRAINY/ROUGH REGIONS WHICH ARE INDICATIVE OF FATIGUE FAILURE. THE EXISTENCE OF TWO SURFACE MORPHOLOGIES IMPLIES THAT THE FRACTURE FIRST PROPAGATED AND THEN FULL FAILURE/BREAKAGE (ROUGH REGION) TOOK PLACE, PRESUMABLY WHEN THE STRENGTH OF THE REMAINING REGION DID NOT HAVE THE STRENGTH TO BEAR THE LOAD. NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD FOUND ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD BE ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOUND NO OBSERVED COMPLAINT TRENDS FOR ISSUES OF THIS NATURE. NO DEFINITIVE CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF ROD BREAKAGE. IT WAS REPORTED THAT THE PATIENT FELL, CAUSING A LOAD ONTO THE CONSTRUCT, WHICH CAUSED THE ROD TO BREAK. HOWEVER, THAT CANNOT BE POSITIVELY DETERMINED. IN THE ABSENCE OF AN IDENTIFIED DEVICE MANUFACTURING/RELEASE ISSUE OR AN OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE INITIAL SURGERY, THE PATIENT FELL AND CREATED A LOAD ONTO CONSTRUCT CAUSING TWO RODS TO BREAK. SEE MFG MEDWATCH REPORT NO. 1526439-2013-00288 FOR THE OTHER SCREW THAT WAS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224941 ACC HEX ROD 5.5X480MM, SS APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP DEPUY SYNTHES SPINE 846352OP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention