BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSKELETON® TAS

    MDR report key: 6443710 · Received March 29, 2017

    Report

    Report Number
    3006340236-2017-00004
    Event Type
    Injury
    Date Received
    March 29, 2017
    Date of Event
    November 28, 2016
    Report Date
    March 28, 2017
    Manufacturer
    TITAN SPINE, LLC
    Product Code
    OVD
    UDI-DI
    M682231202170
    PMA / PMN Number
    K111626
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ENDOSKELETON TAS 12 DEG LORDOTIC, IMPLANT, LARGE, 17 MM (P/N: 2312-0216, LOT: A120246) WAS IMPLANTED WITH TWO TAS 5.5 MM DIA, STANDARD, BONE SCREWS 30 MM (P/N: 2300-5530, LOT: V13 AND V01) AND ONE TAS 6.5 MM DIA, STANDARD BONE SCREW, 25 MM (P/N: 2300-6525, LOT: V03) ON (B)(6) 2016. THE DEVICES WERE DISCARDED BY THE HOSPITAL'S STERILE PROCESSING. FURTHER INVESTIGATION ON THE DEVICES COULD NOT BE PERFORMED. A REVIEW OF THE PRODUCTS' DEVICE HISTORY RECORD WAS PERFORMED FOR THE SUBJECT DEVICES. THE REVIEW REVEALED THERE WERE NO ANOMALIES OR NON-CONFORMANCES GENERATED DURING THE MANUFACTURE OF THESE DEVICES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICES PASSED INSPECTION AND WERE APPROVED FOR INITIAL USE. TITAN SPINE REQUESTED FOR IMAGES (CT OR FLUOROSCOPY) FROM THE SURGERY. THESE HAVE YET TO BE RECEIVED BY TITAN SPINE FOR INVESTIGATION TO BE PERFORMED. THUS, THE ROOT CAUSE OF THIS COMPLAINT CONDITION COULD NOT BE DETERMINED AT THIS TIME. IF IMAGES ARE RECEIVED, A FOLLOW UP REPORT WILL BE COMPLETED WITH THE INVESTIGATION RESULTS. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    A L5-S1 ALIF PROCEDURE WAS COMPLETED ON (B)(6) 2016. SCREW EXTENDED BEYOND POSTERIOR BORDER OF IMPLANT ONCE SEATED AND IMPINGED THE NERVE. THE IMPLANT WAS REMOVED AND REPLACED ON (B)(6) 2017. PATIENT HAS BLADDER RELATED ISSUES DUE TO NERVE DAMAGE. PATIENT HAS FOOT DROP DUE TO NERVE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224572 ENDOSKELETON® TAS 12 DEG LORDOTIC, IMPLANT, LARGE, 17MM OVD TITAN SPINE, LLC 2312-0217 A120246 M682231202170

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S