BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSTERIOR AXIAL DEVICE - TITANIUM ROMEO 2 PAD

    MDR report key: 20331379 · Received September 30, 2024

    Report

    Report Number
    3007728266-2024-00013
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    July 24, 2024
    Report Date
    October 23, 2024
    Manufacturer
    SPINEART SA
    Product Code
    PEK
    UDI-DI
    07640151087586
    PMA / PMN Number
    K141508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER WE RECEIVED THE COMPLAINT, THE DEVICE HISTORY RECORD FOLDER HAS BEEN REVIEWED. THE MANUFACTURING PROCESS AND THE QUALITY CONTROLS ARE CONFORMING TO THE SPECIFICATIONS. THERE WAS NO NON-CONFORMITY OBSERVED DURING THE MANUFACTURING PROCESS. THE INVOLVED DEVICE BELONGS TO A BATCH OF (B)(4) UNITS MANUFACTURED ON 28.MAR.2024. (B)(4) DEVICES HAVE ALREADY BEEN IMPLANTED AND THIS IS THE FIRST TIME WE RECEIVE A COMPLAINT REPORTING THIS KIND OF ISSUE BEFORE WE RECEIVE THE INVOLVED DEVICE, WE DECIDED TO CHECK THE BATCH NUMBER 8-0047 AND WE ANALYZED 1 PART FROM OUR STOCK. IT IS CONFORMING TO THE SPECIFICATION; THE DEVICE WAS CORRECTLY ASSEMBLED, AND IT WAS NOT POSSIBLE TO DISASSEMBLE THE PAD OR TO MOVE A PLATE. WE ARE WAITING FOR THE EXPLANTED INVOLVED DEVICE TO INVESTIGATE.

    Additional Manufacturer Narrative · 0

    AFTER WE RECEIVED THE COMPLAINT, THE DEVICE HISTORY RECORD FOLDER HAS BEEN REVIEWED. THE MANUFACTURING PROCESS AND THE QUALITY CONTROLS COMPLY WITH SPECIFICATIONS. THERE WAS NO NON-CONFORMITY OBSERVED DURING THE MANUFACTURING PROCESS. THE INVOLVED DEVICE BELONGS TO A BATCH OF (B)(4) UNITS MANUFACTURED ON MARCH 28, 2024. (B)(4) DEVICES HAVE ALREADY BEEN IMPLANTED AND THIS IS THE FIRST TIME WE RECEIVE A COMPLAINT REPORTING THIS KIND OF ISSUE. WE RECEIVED THE POSTOPERATIVE PICTURES AND WE DID NOT IDENTIFY ANY ISSUE. BEFORE WE RECEIVE THE INVOLVED DEVICE, WE DECIDED TO CHECK THE BATCH NUMBER 8-0047 AND WE ANALYZED 1 PART FROM OUR STOCK. IT IS IN LINE WITH SPECIFICATION; THE DEVICE WAS CORRECTLY ASSEMBLED, AND IT WAS NOT POSSIBLE TO DISASSEMBLE THE PAD OR TO RELEASE A PLATE. WE RECEIVED THE INVOLVED DISASSEMBLED DEVICE ON OCTOBER 22, 2024. IT HAS BEEN REASSEMBLED BY THE R&D TEAM AND IT WAS FOUND THAT THE DEVICE WAS FUNCTIONAL, IT WAS CORRECTLY LOCKED WITHOUT ANY POSSIBILITY TO RELEASE A PLATE. WE DID NOT DETECT ANY ISSUE, THE DEVICE IS FUNCTIONAL. THE REPORTED CASE IS NOT AN INCIDENT AS IT IS NEITHER A MALFUNCTION NOR A DETERIORATION IN THE CHARACTERISTICS OR PERFORMANCE OF THE DEVICE. THE CASE IS NOT REPORTABLE.

    Description of Event or Problem · 0

    ON 04 SEP 2024, WE RECEIVED A COMPLAINT FROM THE FIELD (SEE (B)(4) FOLDER), FROM ITALY. THE CUSTOMER COMPLAINT FORM REPORTS THAT "PLATE DOESN'T LOCK TO TITANIUM CORE AS IT SHOULD". PLUS, WE WERE INFORMED THAT "THE SURGEON WILL HAVE TO RE OPERATE THE PATIENT, REMOVE THE PAD AND USE A NEW ONE".

    Description of Event or Problem · 0

    ON SEPTEMBER 4, 2024, WE RECEIVED A COMPLAINT FROM THE FIELD (SEE CPT-3191 FOLDER), FROM ITALY. THE CUSTOMER COMPLAINT FORM REPORTS THAT "PLATE DOESN'T LOCK TO TITANIUM CORE AS IT SHOULD". WE WERE INFORMED ON SEPTEMBER 4, 2024, THAT "THE SURGEON WILL HAVE TO RE OPERATE THE PATIENT, REMOVE THE PAD AND USE A NEW ONE". THEN WE WERE INFORMED ON OCTOBER 11, 2024, THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040300 POSTERIOR AXIAL DEVICE - TITANIUM ROMEO 2 PAD POSTERIOR AXIAL DEVICE - TITANIUM ROMEO 2 PAD PEK SPINEART SA PAD-IM TI 08-S 8-0047 07640151087586

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention