BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALIS

    MDR report key: 1548182 · Received November 23, 2009

    Report

    Report Number
    1548182
    Event Type
    Malfunction
    Date Received
    November 23, 2009
    Date of Event
    November 23, 2009
    Report Date
    November 23, 2009
    Manufacturer
    CODMAN
    Product Code
    HAO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING LEFT LAMINOTOMY, DISKECTOMY, AND DECOMPRESSION OF THE LEFT S1 NERVE ROOT AND THECAL SAC AT L5-S1. USE OF OPERATING MICROSCOPE FOR LUMBAR RADICULITIS L5-S1; LUMBAR DISK HERNIATION L5-S1; AND LUMBAR SPONDYLOSIS L5-S1. PASSES WERE MADE WITH A MALIS 80-1531 NERVE HOOK WITH A BALL TIP TO REMOVE DEGENERATIVE DISK FRAGMENTS. WHEN SURGEON REMOVED MALIS 80-1531 NERVE HOOK, IT WAS NOTICED THAT THE BALL TIP WAS MISSING. SURGEON REMOVED BALL TIP. A FINAL LATERAL RADIOGRAPH WAS TAKEN DUE TO FAILURE OF THE NERVE HOOK TO ASSURE THAT BALL TIP WAS COMPLETELY RECOVERED. SURGERY COMPLETED WITHOUT FURTHER INCIDENT. PT WAS TRANSPORTED TO RECOVERY ROOM IN SATISFACTORY CONDITION.

    Description of Event or Problem · 1

    PATIENT UNDERGOING LEFT LAMINOTOMY, DISKECTOMY, AND DECOMPRESSION OF THE LEFT S1 NERVE ROOT AND THECAL SAC AT L5-S1. USE OF OPERATING MICROSCOPE FOR LUMBAR RADICULITIS L5-S1; LUMBAR DISK HERNIATION L5-S1; AND LUMBAR SPONDYLOSIS L5-S1. PASSES WERE MADE WITH A MALIS 80-1531 NERVE HOOK WITH A BALL TIP TO REMOVE DEGENERATIVE DISK FRAGMENTS. WHEN SURGEON REMOVED MALIS 80-1531 NERVE HOOK, IT WAS NOTICED THAT THE BALL TIP WAS MISSING. SURGEON REMOVED BALL TIP. A FINAL LATERAL RADIOGRAPH WAS TAKEN DUE TO FAILURE OF THE NERVE HOOK TO ASSURE THAT BALL TIP WAS COMPLETELY RECOVERED. SURGERY COMPLETED WITHOUT FURTHER INCIDENT. PT WAS TRANSPORTED TO RECOVERY ROOM IN SATISFACTORY CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALIS NERVE HOOK HAO CODMAN 80-1531 *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR