BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMBER INTERBODY FUSION SYSTEM INSTRUMENTATION

    MDR report key: 500927 · Received December 11, 2003

    Report

    Report Number
    2184052-2003-00028
    Event Type
    Injury
    Date Received
    December 11, 2003
    Date of Event
    May 18, 1998
    Report Date
    December 11, 2003
    Manufacturer
    CENTERPULSE SPINE-TECH
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED TO SURGERY IN 1998 FOR A LUMBAR INTERBODY FUSION PROCEDURE AT L4/L5 AND L5/S1 DUE TO A HERNIATED LUMBAR DIC AND LUMBAR INSTABILITY. THE FOLLOWING WERE IMPLANTED DURING THE PROCEDURE: AT L5/S1 -- ONE 17 X 20 MM BAK/PROXIMITY CAGE, PART#8001-1720-00, LOT#P970163; ONE 17 X 20 MM BAK/PROXITY CAGE, PART# 8001-1720-00, LOT#P970165; AT L4/L5 -- ONE 19 X 24 MM BAK/PROXIMITY CAGE, PART# 8001-1924-00, LOT#P970255; ONE 19 X 24 MM BAK/PROXIMITY CAGE, PART# 8001-1924-00, LOT# P970213. DURING THE PLACEMENT OF ONE OF THE CAGES AT L4/5, THE DRILL TUBE GAVE WAY AND THE REAMER BECAME ENTANGLED IN THE LEFT ILIAC VEIN. THIS PRODUCED COPIOUS VENOUS BLEEDING AND THE DRILL TUBE WAS REMOVED. AFTER THE BLEEDING WAS CONTROLLED, THE REMAINING CAGES WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMBER INTERBODY FUSION SYSTEM INSTRUMENTATION BAK/PROXIMITY DRILL TUBE LXH CENTERPULSE SPINE-TECH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention