BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRAIGHT ROD TITANIUM PERLA

    MDR report key: 20320774 · Received September 27, 2024

    Report

    Report Number
    3007728266-2024-00014
    Event Type
    Injury
    Date Received
    September 27, 2024
    Date of Event
    May 8, 2023
    Report Date
    September 27, 2024
    Manufacturer
    SPINEART SA
    Product Code
    NKG
    UDI-DI
    07640178976917
    PMA / PMN Number
    K153386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WHEN WE RECEIVED THE COMPLAINT (B)(4) ON 20.SEP.2024, THE REFERENCE AND THE BATCH NUMBER OF THE EXPLANTED ROD WERE NOT AVAILABLE. NEITHER THE PI NOR THE MONITOR COULD FIND THE LABEL. BASED ON THE INVOICES, WE IDENTIFIED THE REFERENCE AND THE BATCH NUMBER OF THE RODS IMPLANTED: CPF-SR T2 40-S, 6-0651. THE MANUFACTURING FOLDER HAS BEEN REVIEWED. THE ANALYSIS OF THE MANUFACTURING DOCUMENTS AND CONTROL QUALITY DOCUMENTS CONFIRMED THAT THE RAW MATERIALS AND PRODUCTION PROCESSES WERE CONFORMING TO THE SPECIFICATIONS. COMPLAINED DEVICE BELONGS TO A BATCH OF (B)(4) UNITS, MANUFACTURED IN JUNE 2021. THIS IS THE FIRST COMPLAINT WE RECEIVE FOR THIS BATCH. WE RECEIVED THE POSTOPERATIVE PICTURES TAKEN ON (B)(6) 2023 AND WE CLEARLY SEE THAT THE ROD IS BROKEN. DEVICE COMPONENT FRACTURE IS A SIDE EFFECT, SPECIFIC TO THE IMPLANT, CLINICALLY WELL-KNOWN, IT IS REPORTED IN THE IFU AND CER. BASED ON THE ABOVE INFORMATION, WE CONCLUDE THAT THIS ISSUE IS NOT LINKED TO A DEVICE DEFICIENCY BUT LINKED TO THE PATIENT CONDITION (RHEUMATOID ARTHRITIS AND DEGENERATIVE DISEASE) AND THE COMPLEXITY OF THE CONSTRUCTION. WE DECIDED TO INFORM FDA VIA (B)(4) BECAUSE THE DEVICE INVOLVED IS US MARKETED.

    Description of Event or Problem · 0

    ON 20.SEP.2024, WE RECEIVED A COMPLAINT FROM THE FIELD, FROM AUSTRIA, REPORTING THAT, AFTER A PERLA SURGERY REALIZED ON (B)(6) 2022, THE PATIENT HEARD A CRACK THEN CRACKLING NOISE IN (B)(6) 2023. RADIOLOGICAL IMAGE SHOWS THE BROKEN ROD. ROD WAS EXPLANTED AND REPLACED ON (B)(6) 2023 (END OF SADE). THE ROD WAS SCRAPPED ON SITE. THE REFERENCE AND THE BATCH NUMBER OF THE EXPLANTED ROD ARE NOT AVAILABLE. NEITHER THE PI NOR THE MONITOR COULD FIND THE LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830336 STRAIGHT ROD TITANIUM PERLA STRAIGHT ROD TITANIUM PERLA NKG SPINEART SA CPF-SR T2 40-S 6-0651 07640178976917

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention