BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGER

    MDR report key: 4994941 · Received July 30, 2015

    Report

    Report Number
    3006494201-2015-00003
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Report Date
    July 29, 2015
    Manufacturer
    CORELINK LLC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION COULD BE OBTAINED ON THE USE OR THE SCENARIO IN HOW THIS OCCURRED. DHR COULD NOT BE REVIEWED AS THE PART AND LOT# WERE NOT OBTAINED. REVIEW OF X-RAYS SHOWS THE ROD UTILIZED WITH THIS CONSTRUCT SEEMED TO BE TOO SHORT FOR THE ACTIVITY DESCRIBED BY THE DISTRIBUTOR AND WAS MOST LIKELY THE CAUSE OF THE DISENGAGEMENT.

    Description of Event or Problem · 1

    THE SET SCREW ON THE SIDE OF THE CONSTRUCT HAS DISENGAGED FROM THE TULIP HEAD. THE DISTRIBUTOR IDENTIFIED THAT THE PATIENT HAD AN OPERATION ON THE (B)(6) 2014. WHEN THE PATIENT BENT OVER AND TWISTED TO PICK SOMETHING UP THE HARDWARE "POPPED". IMPLANTS WERE NOT REMOVED AT THE TIME OF COMPLAINT NOTICE TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499074 TIGER PEDICLE SCREW HWC CORELINK LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other