BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL PROTI 360

    MDR report key: 10084045 · Received May 22, 2020

    Report

    Report Number
    3012966183-2020-00003
    Event Type
    Malfunction
    Date Received
    May 22, 2020
    Date of Event
    April 27, 2020
    Report Date
    April 27, 2020
    Manufacturer
    TYBER MEDICAL LLC
    Product Code
    MAX
    UDI-DI
    00819917021769
    PMA / PMN Number
    K172185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER HAS OPTED NOT TO RETURN THE DEVICE FOR PRODUCT EVALUATION. HOWEVER, X-RAY IMAGES WERE PROVIDED AND EVALUATED. WHILE A ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED BASED ON THESE IMAGES, THEY DO SUGGEST THAT THE IMPLANT WAS UNDERSIZED AND NOT IDEALLY POSITIONED IN THE DISC SPACE. NO CAPA AND NO TRENDS HAVE BEEN IDENTIFIED. COMPLAINTS OF THIS NATURE ARE MONITORED THROUGH TRACKING AND TRENDING. (B)(4).

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THE INVESTIGATION, THERE WAS NO CAPA AND NO TRENDS ASSOCIATED WITH THIS EVENT TYPE. THE PRODUCT HAS NOT YET BEEN RETURNED FOR EVALUATION, AND THEREFORE THE INVESTIGATION IS STILL PENDING. A REVIEW OF LOT 112013 WAS CONDUCTED. THERE WAS ONE NONCONFORMANCE ASSOCIATED WITH THIS MANUFACTURING LOT. 3 PIECES WERE IDENTIFIED AS MISSING COATING, AND WERE SCRAPPED. 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. NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    "ON (B)(6) 2019 A MIS-TLIF (MINIMALLY INVASIVE SURGERY - TRANSFORAMINAL LUMBAR INTERBODY FUSION) WAS PERFORMED TO TREAT RIGHT INTERVERTEBRAL ARTHRITIS IN L5/S. ON (B)(6) 2020 IT WAS REPORTED THAT THE CAGE HAD BACKED OUT. ON (B)(6) THE PATIENT WILL UNDERGO A REVISION PROCEDURE. THE SURGEON COMMENTED AS FOLLOWS: 1. S/HE WONDERED IF EXCESSIVE LOAD MIGHT HAVE PUT THE CAGE TO MOVE BACKWARD DUE TO THE TIP'S TAPERED SHAPE. 2. IN ADDITION TO THE PRODUCT'S DEFECTIVENESS, IF ANY, MISMATCHING OF CAGE SIZE AND/OR THE CAGE'S DEPLOYED LOCATION MIGHT HAVE TRIGGERED THE EVENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547554 T-PAL PROTI 360 INTERBODY SPACER SYSTEM MAX TYBER MEDICAL LLC 108812210 112013 00819917021769

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention