BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM ROD

    MDR report key: 3163123 · Received June 11, 2013

    Report

    Report Number
    1526439-2013-18615
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 27, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    KWP
    PMA / PMN Number
    PUNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY SYNTHES SPINE HAS REQUESTED RETURN OF THE DEVICES FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE DEVICES AND COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ONE POLYAXIAL SCREW WAS RETURNED FOR EVALUATION. VISUAL INSPECTION NOTED SIGNIFICANT MATERIAL WEAR AROUND THE TULIP SLOT OF THE SCREW. NO OTHER VISUAL ANOMALIES WERE NOTED DURING THE DEVICE EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED NO DISCREPANCIES. TWO SET SCREWS WERE RETURNED FOR EVALUATION. VISUAL INSPECTION NOTED THAT ONE OF THE SET SCREWS HAS SIGNIFICANT WEAR ON THE BOTTOM FACE. THE OTHER SET SCREW SHOWED SIGNS OF MINOR WEAR. THE OBSERVED WEAR PATTERN ON THE SET SCREWS IS MOST LIKELY A RESULT OF THE ROD IMPINGING ON THE SET SCREW AFTER THE REPORTED SLIPPAGE OCCURRED. A REVIEW OF THE DHR IDENTIFIED NO DISCREPANCIES. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOUND NO RELATED COMPLAINTS SUGGESTING THAT THIS IS AN ISOLATED EVENT. A REVIEW OF THE PROVIDED X-RAY WAS CONDUCTED WITH MEDICAL DIRECTOR. REVIEW OF THE X-RAY CONFIRMED THAT THE ROD HAD SLIPPED OUT OF THE SCREW. HOWEVER, THE IMAGE QUALITY WAS POOR WHICH PREVENTED FURTHER EVALUATION. BASED ON THE PROVIDED INFORMATION AND POOR X-RAY IMAGE QUALITY, THE ROOT CAUSE OF THE ROD SLIPPAGE IS UNKNOWN. NO CORRECTIVE ACTION IS REQUIRED AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE AND THERE HAS BEEN NO OBSERVED SYSTEMIC TREND. THEREFORE, THE COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF ADDITIONAL DETAILS ARE PROVIDED, THE COMPLAINT WILL BE RE-OPENED AND REEVALUATED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE ROD HAD SLIPPED OUT OF POLYAXIAL SCREW HEADS TO WHICH THE SET SCREWS WERE ASSEMBLED. REVISION SURGERY WAS PERFORMED TO REMOVE THE DEVICES. CONCOMITANT DEVICES: EXPEDIUM SINGLE INNIE SET SCREWS, 188102000, QUANTITY = 2. EXPEDIUM POLYAXIAL SCREWS, 188112640, QUANTITY = 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264420 EXPEDIUM ROD APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP DEPUY SYNTHES SPINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention