BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CETRA

    MDR report key: 15508931 · Received September 29, 2022

    Report

    Report Number
    2183449-2022-00004
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    September 13, 2022
    Report Date
    April 4, 2024
    Manufacturer
    ORTHOFIX MEDICAL INC
    Product Code
    KWQ
    UDI-DI
    18257200120383
    PMA / PMN Number
    K162638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CETRA PLATE (PN:19-0232 LN:E08) WAS RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT 1 LOCKING TAB BROKE IN-SITU. THE CASE WAS C4/6 AND IT WAS AT C6 THAT IT BROKE (BREAK OCCURRED AT THE CAUDAL END). THE LOCKING TAB HAD SHEARED OFF AT THE LOCATION OF SMALLEST CROSS-SECTION IN THE DESIGN. FAILURE LIKELY OCCURRED BECAUSE OF DUCTILE OVERLOAD OF THE LOCKING TAB. THE LOCKING TAB COULD HAVE BEEN SUBJECTED TO OVERLOAD DUE TO SCREWS LEFT PROUD OR EXTREME ANGULATION . THE CETRA OPERATIVE TECHNIQUE CONTAINS THIS NOTE IN SECTION 10 (SCREW LOCKING MECHANISM) - "NOTE: CONFIRM THAT ALL SCREWS HAVE BEEN FULLY SEATED IN THE PLATE BEFORE LOCKING." PROUD SCREWS CREATE UNINTENDED CONTACT AND LOADING WITH THE LOCKING TAB. ONE OF THE LOCKING TABS THAT IS BROKEN SHOWS CONTACT MARKS WITH THE 2 SCREWS AT THAT LEVEL. A REVIEW OF THE PRODUCT DHR SHOWED THAT ALL INSPECTIONS MET DESIGN SPECIFICATIONS. A REVIEW OF AGILE NCMR DATABASES DID NOT REVEAL ANY NON-CONFORMANCES RELATED TO THIS INVESTIGATION.

    Description of Event or Problem · 0

    PRODUCT WAS RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 0

    INFORMATION PROVIDED STATES THAT THE LOCKING MECHANISM ON A CERVICAL PLATE BECAME DISLODGED. A REVISION SURGERY WAS PERFORMED TO REPLACE THE PLATE AND SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1584119 CETRA CETRA ANTERIOR CERVICAL PLATE KWQ ORTHOFIX MEDICAL INC E08 18257200120383

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Other