BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE GAMMA3 300X160MM

    MDR report key: 2990054 · Received March 5, 2013

    Report

    Report Number
    0009610622-2013-00091
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: EVALUATION REVEALED THAT THE TARGET DEVICE DID NOT CONTRIBUTE TO THE COMPLAINED EVENT, THEREFORE IT WAS CLASSIFIED AS CONCOMITANT ITEM.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT GAMMA NAIL WAS USED TO TREAT PATIENTS HIP FX. AT THE CONCLUSION OF THE CASE AFTER TAKING FINAL X-RAYS, THE TARGETER WOULD NOT DISENGAGE FROM THE GAMMA NAIL. AS A RESULT, WE HAD TO REMOVE THE NAIL FROM THE PATIENT AND INSERT A NEW GAMMA NAIL INSTEAD. THE OUTCOME WAS SATISFACTORY AND DIDN'T COMPROMISE THE PATIENT IN THE OR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT GAMMA NAIL WAS USED TO TREAT PATIENTS HIP FX. AT THE CONCLUSION OF THE CASE AFTER TAKING FINAL X-RAYS, THE TARGETER WOULD NOT DISENGAGE FROM THE GAMMA NAIL. AS A RESULT, WE HAD TO REMOVE THE NAIL FROM THE PATIENT AND INSERT A NEW GAMMA NAIL INSTEAD. THE OUTCOME WAS SATISFACTORY AND DIDN'T COMPROMISE THE PATIENT IN THE OR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93184 TARGET DEVICE GAMMA3 300X160MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL K229159

    Patients

    Seq Age Sex Outcome Treatment
    1 Other