BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPIOS BONE VOID FILLER - PASTE

    MDR report key: 3022754 · Received March 22, 2013

    Report

    Report Number
    2530154-2013-00001
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    October 15, 2012
    Report Date
    March 22, 2013
    Manufacturer
    KENSEY NASH CORP.
    Product Code
    MQV
    PMA / PMN Number
    K072384
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: LOT HISTORY RECORDS REVIEWED. STERILIZATION CERTIFICATES AND RESULTS WERE REVIEWED. RESULTS: NO UNPLANNED DEVIATIONS WERE FOUND DURING LOT HISTORY RECORDS REVIEW. PRODUCT WAS PROCESSED TO SPECIFIED STERILIZATION PARAMETERS. NO ROOT CAUSE CAN BE DETERMINED. RELEVANT MEDICAL HISTORY AND CLINICAL OUTCOME INFORMATION HAS BEEN REQUESTED. INVESTIGATION: THE DEVICE HISTORY RECORDS FOR KNC LOT NUMBERS 99785 AND A4498 HAVE BEEN REVIEWED. THERE WERE NO UNPLANNED DEVIATIONS FOUND. STERILIZATION CERTIFICATES AND RESULTS WERE REVIEWED. ALL PRODUCT WAS PROCESSED TO SPECIFIED STERILIZATION PARAMETERS. REVIEW OF PREVIOUS COMPLAINTS: THERE HAVE BEEN NO OTHER COMPLAINTS OF INFECTION INVOLVING COPIOS PASTE, NOR HAVE THERE BEEN REPORTED CASES OF INFECTION INVOLVING COPIOS PASTE. ROOT CAUSE: IN THE ABSENCE OF PHYSICAL EVIDENCE OR PATHOLOGY TO SUPPORT INFECTION, KENSEY NASH CANNOT PROVIDE A DEFINITIVE ROOT CAUSE FOR THIS INCIDENT. CORRECTIVE ACTIONS: AS NO ROOT CAUSE CAN BE ASSIGNED, NO SPECIFIC ACTION TO ADDRESS THE FAILURE IS INITIATED. KENSAY NASH WILL CONTINUE TO MONITOR FOR LIKE RE-OCCURRENCES AND INITIATE APPROPRIATE ACTIONS AS WARRANTED.

    Description of Event or Problem · 1

    THE PATIENT HAD A 3 LEVEL LUMBAR FUSION SURGERY. DURING SURGERY TWO 10CC COPIOS PASTE PRODUCTS WERE PLACED IN THE LATERAL GUTTERS ALONG WITH SEQUOIA SCREWS AND RODS. AT SOME POINT POST-OPERATIVE, THE PATIENT DEVELOPED POST-OPERATIVE INFECTION. APPROXIMATELY 3 WEEKS AFTER THE INITIAL SPINAL FUSION, THE PATIENT UNDERWENT REVISION SURGERY. DURING REVISION SURGERY, A BROWNISH FLUID WAS FOUND FROM THE INFERIOR PORTION OF THE INCISION. COPIOS WAS REMOVED AS PART OF STANDARD HOSPITAL INFECTION CONTROL PROCEDURES ALONG WITH IRRIGATION AND DEBRIDEMENT OF THORACOLUMBAR WOUND. THE METAL IMPLANTS WERE NOT REMOVED DURING REVISION SURGERY AND HAVE REMAINED IN PLACE. THE CAUSE OF THE INFECTION IS NOT KNOWN. NO OUTCOME INFORMATION WAS AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120834 COPIOS BONE VOID FILLER - PASTE RESORBABLE CALCIUM SALT BONE VOID FILLER MQV KENSEY NASH CORP. 20100-03 99785

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention SEQUOIA PEDICLE SCREW SYSTEM