BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T PAL PRO TI 12 X 8 X 32MM

    MDR report key: 11977266 · Received June 10, 2021

    Report

    Report Number
    3012966183-2021-00013
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Date of Event
    May 12, 2021
    Report Date
    June 10, 2021
    Manufacturer
    TYBER MEDICAL
    Product Code
    MAX
    UDI-DI
    00819917021745
    PMA / PMN Number
    K172185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS INVESTIGATION THERE WA NO TREND OR CAPA IDENTIFIED FOR THIS EVENT TYPE. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFOMRANCES OR DEVIATIONS. THE LOT WAS MANUFACTURED PER SPECIFICATIONS AND MET ACCEPTANCE CRITERIA. COMPLAINTS OF THIS NATURE ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED FURTHER INVESTIGATION SHALL BE CONDUCTED THROUGH THE CAPA/ CONTINUOUS IMPROVEMENT PROCESS. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE CAGE DEPLOYMENT, THE SURGEON DID NOT NOTICE THAT THE HOLDER HAPPENED TO LEAN OUTWARD. WITHOUT NOTICING THAT HE TAPPED THE CAGE. THEN THE CAGE BROKE. BECAUSE THE CAGE HAD BEEN DEPLOYED DEEP IN THE INTERVERTEBRAL LESION, HE DECIDED NOT TO EXTRACT IT. THE PROCEDURE WAS COMPLETED IN LESS THAN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874457 T PAL PRO TI 12 X 8 X 32MM INTERBODYSPACER SYSTEM MAX TYBER MEDICAL 108812208 206146 00819917021745

    Patients

    Seq Age Sex Outcome Treatment
    1 Other