BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNFIX-LR

    MDR report key: 2010665 · Received February 25, 2011

    Report

    Report Number
    1719045-2011-00101
    Event Type
    Injury
    Date Received
    February 25, 2011
    Report Date
    January 27, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MAX
    PMA / PMN Number
    K072253
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS NOT PROVIDED DURING INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. APPROXIMATE IMPLANT DATE: (B)(6) 2006. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    FROM A JOURNAL ARTICLE: PATIENT PRESENTED WITH LOW BACK PAIN RESISTANT TO THERAPY. X-RAYS SHOWED DDD L5/S1. ON (B)(6) 2006, ANTERIOR LEFT RETROPERITONEAL APPROACH USED FOR ALIF PROCEDURE WITH SYNFIX DEVICE, AT THE L5/S1. LUMBAR X-RAYS REVEALED NO DISLOCATION OF SCREWS AND GOOD PLACEMENT OF THE IMPLANT. POSTOP TESTS SHOWED A DROP OF HEMOGLOBIN VALUE. CT SCAN SHOWED LARGE ABDOMINAL WALL HEMATOMA. INJURY OF RIGHT AND LEFT EPIGASTRIC INFERIOR ARTERIES MAY BE DUE TO ARTERIOSCLEROSIS; EXCESSIVE DISTENSION DURING INSERTION OF SCREWS AND OR TRACTION. NO INTRAOPERATIVE BLEEDING NOTED DURING INDEX SURGERY. AT 6 MONTHS FOLLOW UP, PATIENT ACHIEVED GOOD CLINICAL AND RADIOLOGIC OUTCOME, NO HEMATOMA RECURRENCE, AND NORMAL LAB VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNFIX-LR SYNFIX-LR MAX SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention SCREWS