BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCORDE PROTI 360

    MDR report key: 10982996 · Received December 10, 2020

    Report

    Report Number
    3012966183-2020-00007
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Report Date
    December 10, 2020
    Manufacturer
    TYBER MEDICAL
    Product Code
    MAX
    UDI-DI
    00819917020779
    PMA / PMN Number
    K172185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE NARRATIVE FOR THE PREVIOUS SUPPLEMENT (MW_3012966183-2020-00007 SUPPLEMENT 2) DID NOT SAVE WHEN THE FORM WAS CREATED. THEREFORE, THIS SUPPLEMENT IS TO INCLUDE THE FINDINGS FROM THE PRODUCT RETURN EVALUATION. THE DEVICE WAS NOT INITIALLY RECEIVED FOR EVALUATION, BUT HAS SINCE BEEN RETURNED AND EVALUATED. VISUAL INSPECTION OF THE RETURNED DEVICE SHOWED THAT THREADS WERE SEVERELY DAMAGED, MOST LIKELY AS A RESULT OF THE EXPLANT PROCEDURE. THE COATED SURFACE HAD SOME SMEARING AND SCRATCHES CONSISTENT WITH TISSUE REMOVAL AND CLEANING OF THE IMPLANT. THE COATED SURFACE WAS NOT CRACKED OR DAMAGED. THE BODY OF THE IMPLANT WAS IN TACT. NO POST-OP PRIMARY SURGERY OR PRE-OP REVISION SURGERY XRAYS WERE RECEIVED FOR ANALYSIS. THEREFORE NO CONCLUSIONS COULD BE DRAWN IN TERMS OF PROPER SIZE OR POSITIONING OF THE IMPLANT IN THE DISC SPACE. THE LOT NUMBER HAS ALSO BEEN PROVIDED, AND A DHR REVIEW CONFIRMED THAT THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS SPECIFIC COMPLAINT TYPE. THE LOT MET SPECIFICATIONS. THERE WERE NO TRENDS AND NO CAPA'S FOR THIS COMPLAINT TYPE. COMPLAINTS OF THIS NATURE ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS IDENTIFIED, FURTHER ACTION WILL BE CONDUCTED THROUGH THE CAPA/CONTINUOUS IMPROVEMENT PROCESS. NO FURTHER ACTION IS REQUIRED AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 0

    CUSTOMER HAS INDICATED THAT DEVICE WOULD BE RETURNED. HOWEVER, TYBER MEDICAL HAS NOT YET RECEIVED THE DEVICE DESPITE MULTIPLE ATTEMPTS. THEREFORE, A ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. IF THE DEVICE IS RETURNED, OR IF ADDITIONAL INFORMATION IS RECEIVED, FURTHER INVESTIGATION WILL BE CONDUCTED. NO CAPA AND NO TRENDS HAVE BEEN IDENTIFIED AT THIS TIME. COMPLAINTS OF THIS NATURE ARE MONITORED THROUGH TRACKING AND TRENDING. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    AT THE TIME OF INITIAL 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 THE LOT COULD NOT BE CONDUCTED AT THIS TIME, AS THERE WAS NO LOT NUMBER PROVIDED. THEREFORE, REVIEW OF THE LOT ASSOCIATED WITH THIS EVENT IS STILL PENDING INVESTIGATION. 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. (B)(4).

    Description of Event or Problem · 1

    "IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD A CONCORDE BULLET PROTI CAGE MIGRATE POSTERIORLY OUT OF THE DISC SPACE. THERE WAS AN UNKNOWN PATIENT CONSEQUENCES. PROCEDURE OUTCOME IS UNKNOWN. PLANNED REVISION SURGERY WAS SCHEDULED ON (B)(6) 2020. THIS COMPLAINT INVOLVES ONE (1) DEVICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1449600 CONCORDE PROTI 360 INTERBODY SPACER SYSTEM MAX TYBER MEDICAL 188823110 151804 00819917020779

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention