BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM 5.5 SS 30MM ROD

    MDR report key: 3200082 · Received July 1, 2013

    Report

    Report Number
    1526439-2013-20103
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    KWP
    PMA / PMN Number
    PK041119
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE BROKEN ROD SECTIONS AND COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED IN THE COMPLAINT FILE THAT A SINGLE ROD WAS CUT AND USED BILATERALLY WITH ONE BREAK ON EACH SIDE OF THE CONSTRUCT. VISUAL INSPECTION OF THE ROD NOTED THIS CUT SURFACE. NO OTHER VISUAL ABNORMALITIES WERE NOTED. A NON DESTRUCTIVE FRACTURE ANALYSIS USING MAGNIFIED OPTICAL IMAGING WAS PERFORMED. OPTICAL IMAGING FOUND EVIDENCE OF FATIGUE STRIATIONS. NO MATERIAL DEFECTS OR ABNORMALITIES WERE OBSERVED IN THE ANALYSIS. A DEVICE HISTORY RECORD SEARCH FOR THE ROD WAS CONDUCTED HEX ROD 5.5X300MM, SS (PRODUCT CODE: 188163300, LOT NO: 744596OP) IDENTIFIED THAT THE LOT WAS RELEASED IN 3 BATCHES ON 6/3/2011, 7/20/2010, AND 8/1/2011. NO 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 COMPLAINT TREND ANALYSIS WAS CONDUCTED FOR ALL EXPEDIUM 5.5. STAINLESS STEEL RODS DUE TO SIMILAR GEOMETRIC DESIGN AND FUNCTIONALITY. NO SYSTEMIC TREND WAS IDENTIFIED. THE ROOT CAUSE OF THE ROD BREAKAGE IS UNDETERMINED HOWEVER OPTICAL FRACTURE ANALYSIS IMAGING FOUND EVIDENCE OF FATIGUE STRIATIONS ON THE FRACTURED SURFACES. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE AND THERE HAS BEEN NO OBSERVED SYSTEMIC TREND THE COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTIONS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO ROD BREAKAGE. DURING THE INITIAL SURGERY, ONE ROD HAD BEEN CUT INTRA-OPERATIVELY TO PRODUCE THE TWO ROD SECTIONS THAT WERE INCLUDED IN THE SPINAL CONSTRUCT. BOTH SECTIONS OF THE ROD WERE FOUND TO BE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298213 EXPEDIUM 5.5 SS 30MM ROD APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP DEPUY SYNTHES SPINE 744596OP

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention