BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2830988 · Received November 14, 2012

    Report

    Report Number
    2520274-2012-03111
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 17, 2012
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT DATE APPROXIMATELY 2004. EXPLANT DATE APPROXIMATELY 2009. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    (B)(6) FEMALE EXPERIENCED MVA IN 2004. THE L5 FRACTURE WAS TREATED WITH SHORT SEGMENT POSTERIOR STABILIZATION: L4-L5 IN FIRST STAGE FOLLOWED BY ANTERIOR L5 CORPECTOMY, INSTRUMENTATION AND FUSION. ANTERIOR STABILIZATION WAS DONE FROM L4-S1 WITH PEDICLE SCREW AND ROD, SYNTHES UNIVERSAL SPINAL SYSTEM. ANTERIOR COLUMN RECONSTRUCTION COMPLETED WITH HARMS MESH CAGE FILLED WITH BONE GRAFT. PATIENT HAD REGULAR FOLLOW UPS FOR 2 YEARS. RADIOGRAPHS SHOWED SIGNS OF ANTERIOR FUSION. AFTER 5 YEARS, PATIENT PRESENTED WITH COMPLAINTS OF OCCASIONAL BLEEDING FROM RECTUM. PATIENT TREATED WITH MEDICATIONS. AFTER 6 MONTHS, PATIENT PRESENTED TO ER WITH COMPLAINTS OF HEAVY BLEEDING FROM THE RECTUM. COLONOSCOPY SHOWED DISTAL END OF ANTERIOR ROD ERODED THE WALL OF THE SIGMOID COLON. CT SCAN SHOWED EROSION OF LEFT COMMON ILIAC ARTERY BY THE PROXIMAL END OF THE IMPLANT. HARDWARE WAS REMOVED APPROXIMATELY 2009. EXPLORATIVE LAPARATOMY AND ADHESIOLYSIS WAS PERFORMED AND SHOWED PERFORATION OF THE RECTOSIGMOID COLON BY THE DISTAL END OF ANTERIOR ROD AND PROXIMAL SCREW HEAD WAS FOUND TO BE ERODING THE LEFT COMMON ILIAC ARTERY. ARTERIAL RECONSTRUCTION PERFORMED, LOW ANTERIOR RESECTION ANASTOMOSIS OF THE RECTUM ALONG WITH DIVERSION LOOP ILEOSTOMY. POST OP PERIOD WAS UNEVENTFUL, AFTER 1 WEEK URETRIC STENT WAS REMOVED, AND AFTER 6 WEEKS COLOSTOMY CLOSURE COMPLETED. REGULAR FOLLOW UPS WERE COMPLETED AND PATIENT RECOVERED FROM CHRONIC ANEMIA. THE REPORTING PRODUCT DEVELOPMENT ENGINEER NOTED: THE USS SYSTEM IS INDICATED FOR ANTEROLATERAL FIXATION FROM T8 TO L5. THE IMAGES WITHIN THE ARTICLE SHOW ANTERIOR PLACEMENT FROM THE LUMBAR SPINE TO THE SACRUM. THE OFF-LABEL USE CONTRIBUTED TO POST OP COMPLICATIONS DESCRIBED IN THE ARTICLE. THIS IS 1 OF 7 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW NKB

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention SCREW, COLLAR, NUT, ROD