BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-PAL PROTI

    MDR report key: 8893944 · Received August 14, 2019

    Report

    Report Number
    3012966183-2019-00002
    Event Type
    Injury
    Date Received
    August 14, 2019
    Date of Event
    July 3, 2019
    Report Date
    August 12, 2019
    Manufacturer
    TYBER MEDICAL
    Product Code
    MAX
    PMA / PMN Number
    172185
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION DEMONSTRATE THAT THE IMPLANT WAS MANUFACTURED PER SPECIFICATION AND THE CAUSE OF THE IMPLANT'S EXPULSION COULD HAVE BEEN DUE TO MULTIPLE VARIABLES SUCH AS THOSE INDICATED BY THE SURGEON IN THE COMPLAINT: INSUFFICIENT DISSECTION; MIS-SELECTION OF THE CAGE SIZE AND DEPLOYMENT. THE EXPULSION WAS MOST LIKELY DUE TO USE ERROR. TYBER MEDICAL WILL CONTINUE TO MONITOR FOR ANY POTENTIAL FUTURE TRENDS.

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THE INVESTIGATION, THERE WAS NO CAPA AND NO TRENDS ASSOCIATED WITH THIS EVENT TYPE. THIS EVENT IS CURRENTLY WAITING ON THE PRODUCT RETURN FOR FURTHER INVESTIGATION. REVIEW OF THE DHR DID NOT SHOW ANY NON-CONFORMANCES ASSOCIATED WITH THIS LOT. THE LOT MET RELEASE REQUIREMENTS. COMPLAINTS OF THIS NATURE ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED THROUGH THE CAPA/CONTINUOUS IMPROVEMENT PROCESS.

    Description of Event or Problem · 1

    WE RECEIVED A COMPLAINT REGARDING PRODUCT CODE, 1088-12-010, LOT NUMBER 112213. DEVICE WAS IMPLANTED ON (B)(6) 2019. IT WAS NOTED ON (B)(6) 2019 DEVICE BACKED OUT WHICH WAS EXTRUDED INTO THE SPINAL CANAL RESULTING IN NEUROLOGICAL SYMPTOMS TO PATIENT. NO SURGICAL DELAY WAS REPORTED. ON (B)(6) THE PATIENT WILL UNDERTAKE REOPERATION FOR REMOVING THE CAGE. DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688599 T-PAL PROTI T-PAL PROTI MAX TYBER MEDICAL 112213

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention