BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL

    MDR report key: 7427483 · Received April 12, 2018

    Report

    Report Number
    2939274-2018-51633
    Event Type
    Injury
    Date Received
    April 12, 2018
    Report Date
    March 20, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    KTT
    UDI-DI
    10886982197825
    PMA / PMN Number
    K161417
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT ID, AGE, DOB AND WEIGHT NOT PROVIDED FOR REPORTING. UNKNOWN WHEN THE C-SPINE (CERVICAL SPINE) MRI WAS ATTEMPTED. ADDITIONAL PRODUCT CODE: LXT. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. ADDITIONAL 510K #'S:K122455, K082650, K033158, K030390. (B)(4). DHR REVIEW COULD NOT BE CONDUCTED DUE TO INSUFFICIENT INFORMATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MED-WATCH, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE, AND A FOLLOW-UP MED-WATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH AN EX-FIX DEVICE EXPERIENCED A MAGNETIC PULL FROM BEING IN THE VICINITY OF MAGNETIC RESONANCE IMAGINING (MRI) AND THE SCAN WAS NOT PERFORMED AS A RESULT. THE PATIENT WAS NOT PUT INTO THE MACHINE. THIS WAS A POLY-TRAUMA (POST MOTORCYCLE ACCIDENT) PATIENT WHO WAS INTUBATED AND HAD A PELVIC EX-FIX IN PLACE SINCE A PROCEDURE ON (B)(6) 2018. HE WAS TO HAVE A C-SPINE (CERVICAL SPINE) MRI. THE PATIENT WAS OBSERVED TO BE KICKING HIS LEGS (HE WAS IN PAIN) IN RELATION TO BEING IN THE MRI AREA; BEING NEAR THE MACHINE WAS ENOUGH TO CAUSE A "PULL" ON HIS EX-FIX DEVICE. THE PLAN FOR THE MRI WAS ABORTED; NO MRI WAS DONE. THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR AN UNEVENTFUL PROCEDURE ON (B)(6) 2018 AT WHICH TIME THE EX-FIX WAS REMOVED. THIS COMPLAINT INVOLVES SEVEN DEVICES, THIS REPORT IS 2 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267787 LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL APPLIANCE,FIXATION,NAIL KTT WRIGHTS LANE SYNTHES USA PRODUCTS LLC 390.005 10886982197825

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention