BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPAL PRO TI 10X 8X 28MM

    MDR report key: 14397556 · Received May 13, 2022

    Report

    Report Number
    3012966183-2022-00017
    Event Type
    Malfunction
    Date Received
    May 13, 2022
    Date of Event
    April 19, 2022
    Report Date
    May 13, 2022
    Manufacturer
    TYBER MEDICAL
    Product Code
    MAX
    UDI-DI
    00819917021639
    PMA / PMN Number
    K172185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD WAS REVIEWED AND THERE WERE NO ISSUES FOUND. THE DEVICE WAS NOT RETURNED SO N EVALUATION WAS NOT PERFORMED. THERE WERE NO NON-CONFORMANCES OR CAPAS ASSOCIATED WITH THIS LOT AND THE LOT MET ACCEPTANCE CRITERIA. EXPULSION FROM A DISC SPACE CAN LEAD TO SERIOUS INJURY, HOWEVER, EXPULSION IS OFTEN DUE TO EXTERNAL FORCES OR POOR CAGE PLACEMENT, NOT CAGE DESIGN. HOWEVER, THE INVESTIGATION WAS NON-CONCLUSIVE AS RADIOGRAPHIC IMAGING AND THE DEVICE WERE NOT RETURNED. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    ON (B)(6) 2022 THE PATIENT UNDERWENT A PRIMARY TLIF (L4-5) PROCEDURE WITHOUT SURGICAL DELAY. ON AN UNKNOWN DATE IT WAS FOUND THAT THE CAGE HAD BACKED OUT. ON (B)(6) THE PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE. THE SURGEON WONDERED IF THE CAGE MIGHT HAVE TRIGGERED THE EVENT. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1898885 TPAL PRO TI 10X 8X 28MM INTERBODY SPACER MAX TYBER MEDICAL 108812088 205910 00819917021639

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other