BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CETRA

    MDR report key: 20570541 · Received October 30, 2024

    Report

    Report Number
    2183449-2024-00021
    Event Type
    Injury
    Date Received
    October 30, 2024
    Date of Event
    October 10, 2024
    Report Date
    January 15, 2025
    Manufacturer
    ORTHOFIX US LLC
    Product Code
    KWQ
    UDI-DI
    18257200120321
    PMA / PMN Number
    K162638
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE 1-LEVEL PLATE ASSEMBLY (PN: 19-0126 LN: E19) WAS RETURNED FOR INVESTIGATION. THE PLATE WAS RETURNED WITH 3 SCREWS. ATTEMPTS MADE TO GATHER ADDITIONAL INFORMATION AND INQUIRE ABOUT THE 4TH SCREW WERE UNSUCCESSFUL. THE EDGES OF THE LOCKING PLATE THAT BROKE OFF ARE DEFORMED, LIKELY FROM CONTACTING THE HEAD OF THE SCREWS. THE SCREW HEADS ALSO SHOW DEFORMATION. THE LOCKING TAB LIKELY FAILED BECAUSE OF DUCTILE OVERLOAD AND DUCTILE SHEAR OVERLOAD ON THE SCREW. THE LOCKING TAB WAS LIKELY SUBJECTED TO OVERLOAD BY LEAVING THE SCREWS PROUD CAUSING THE LOCKING TAB TO STRESS AT FILLET WHICH IS WEAKER CROSS SECTION OF THE DESIGN. A REVIEW OF THE PRODUCT DHR SHOWED THAT ALL INSPECTIONS MET DESIGN SPECIFICATIONS. A REVIEW OF THE NCMR DATABASES DID NOT REVEAL ANY NONCONFORMANCES RELATED TO THIS INVESTIGATION.

    Additional Manufacturer Narrative · 0

    PRODUCT HAS NOT RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT HAD ACDF ON (B)(6) 2023. A PLANNED REVISION ACDF C6/7 WAS PERFORMED ON THE PATIENT ON (B)(6) 2024. ON (B)(6) 2024 THE PATIENT HAD A REMOVAL OF THE CETRA PLATE DUE TO IT BECOMING LOOSE FROM THE (B)(6) 2024 SURGERY. IT WAS REPORTED THAT UPON REMOVAL THE C6 LOCKING MECHANISM WAS SHEERED OFF.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT HAD ACDF (B)(6) 2023. A PLANNED REVISION ACDF C6/7 WAS PERFORMED ON THE PATIENT (B)(6) 2024. ON (B)(6) 2024 THE PATIENT HAD A REMOVAL OF THE CETRA PLATE DUE TO IT BECOMING LOOSE FROM THE (B)(6) 2024 SURGERY. IT WAS REPORTED THAT UPON REMOVAL THE C6 LOCKING MECHANISM WAS SHEERED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1960246 CETRA 1-LEVEL PLATE ASSEMBLY, 26MM KWQ ORTHOFIX US LLC 19-0126 E19 18257200120321

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other