BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL HOLDING SCREW GAMMA3 8X35MM

    MDR report key: 3244141 · Received July 24, 2013

    Report

    Report Number
    0009610622-2013-00411
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION CONCLUSION: EVALUATION REVEALED THAT THE NAIL HOLDING SCREW WITH LOT CODE K391539 DID NOT CONTRIBUTE TO THE COMPLAINED EVENT, THEREFORE IT WAS CLASSIFIED AS CONCOMITENT ITEM.

    Description of Event or Problem · 1

    WE IMPLANTED THE ROD, PUT THE LAG SCREW AND DISTAL SCREW IN. ONCE EVERYTHING WAS IMPLANTED AND ATTEMPTED TO DISENGAGE, THE OUTRIGGER TO THE IMPLANT, IT WOULD NOT RELEASE. THE DOCTOR TRIED WITH ALL OF HIS STRENGTH BUT COULD NOT GET IT RELEASED. THE DISTAL LOCKING SCREW AND LAG SCREW HAD TO BE REMOVED AS WELL AS THE ROD. EVEN AFTER REMOVING THE CONSTRUCT FROM THE PATIENT, THE ROD STILL COULD NOT BE SEPARATED FROM THE INSTRUMENT. THEY BEGAN MALLET AND HAD TO FORCIBLY REMOVE THE ROD FROM THE INSTRUMENT. THE SECOND IMPLANTATION ATTEMPT WAS SUCCESSFUL.

    Description of Event or Problem · 1

    WE IMPLANTED THE ROD, PUT THE LAG SCREW AND DISTAL SCREW IN. ONCE EVERYTHING WAS IMPLANTED AND ATTEMPTED TO DISENGAGE THE OUTRIGGER TO THE IMPLANT, IT WOULD NOT RELEASE. THE DOCTOR TRIED WITH ALL OF HIS STRENGTH BUT COULD NOT GET IT RELEASED. THE DISTAL LOCKING SCREW AND LAG SCREW HAD TO BE REMOVED AS WELL AS THE ROD. EVEN AFTER REMOVING THE CONSTRUCT FROM THE PATIENT, THE ROD STILL COULD NOT BE SEPARATED FROM THE INSTRUMENT. THEY BEGAN MALLET AND HAD TO FORCIBLY REMOVE THE ROD FROM THE INSTRUMENT. THE SECOND IMPLANTATION ATTEMPT WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345387 NAIL HOLDING SCREW GAMMA3 8X35MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL K391539

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other