BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOWERLOX

    MDR report key: 7095740 · Received December 7, 2017

    Report

    Report Number
    3006082533-2017-00008
    Event Type
    Injury
    Date Received
    December 7, 2017
    Report Date
    November 17, 2017
    Manufacturer
    CAPTIVA SPINE
    Product Code
    MNI
    PMA / PMN Number
    K131538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CAPTIVA SPINE WAS CONTACTED BY A PATIENT INDICATING THAT THERE WAS A FRACTURED PEDICLE SCREW. CAPTIVA SPINE CONTACTED THE SURGEON TO OBTAIN FURTHER INFORMATION REGARDING THE REPORTED INCIDENT. THE ORIGINAL PROCEDURE WAS COMPLETED ON (B)(6) 2013. THE SURGEON INDICATED THAT DURING A FOLLOW UP VISIT COMPLETED IN (B)(6) 2014, THERE WAS NO EVIDENCE OF A BROKEN SCREW AT THAT TIME. THE PATIENT RETURNED IN (B)(6) 2014 COMPLAINING OF CHRONIC BACK PAIN. A CT WAS PERFORMED IN (B)(6) 2014 AND THERE WAS EVIDENCE OF FUSION AS WELL AS TWO BROKEN SCREWS IN THE SACRUM. WHILE THE SURGEON DID NOT THINK THAT THE BROKEN SCREWS WOULD CONTRIBUTE TO THE BACK PAIN THE DECISION WAS TO REMOVE ALL THE HARDWARE. THE SURGEON DID INDICATE THAT THE PATIENT'S JOB WHICH REQUIRES HEAVY LIFTING WAS THE MOST LIKELY CAUSE OF THE BACK PAIN, WHICH IS ATYPICAL WITHIN 12 MONTHS OF SURGERY. THERE HAVE BEEN NO ADDITIONAL REPORTS REGARDING THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876283 TOWERLOX THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM MNI CAPTIVA SPINE 2431-6545

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention