BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CETRA

    MDR report key: 20250789 · Received September 18, 2024

    Report

    Report Number
    2183449-2024-00016
    Event Type
    Injury
    Date Received
    September 18, 2024
    Date of Event
    August 20, 2024
    Report Date
    October 22, 2024
    Manufacturer
    ORTHOFIX
    Product Code
    KWQ
    UDI-DI
    18257200120680
    PMA / PMN Number
    K162638
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE IS NOT RETURNING FOR INVESTIGATION. REP STATED THAT THE TWO INFERIOR SCREWS FAILED LOCKING MECHANISM WAS REMOVED AND THEN DISCARDED PER BANNER POLICY. THE 4-LEVEL PLATE ASSEMBLY (PN: 19-0478, LN: E12) WAS NOT RETURNED FOR INVESTIGATION. HOWEVER, BASED ON THE X-RAY IMAGE PROVIDED IT CAN BE CONFIRMED THAT A SCREW IS BACKING OUT AND THE LOCKING TAB HAS PULLED AWAY FROM THE PLATE. IT IS POSSIBLE THE LOCKING TAB COULD HAVE BEEN SUBJECTED TO OVERLOAD BY LEAVING THE SCREWS PROUD CAUSING THE LOCKING TAB TO STRESS AT FILLET WHICH IS A WEAKER CROSS SECTION OF THE DESIGN. HOWEVER, WITH THE LIMITED AVAILABLE INFORMATION AND THE DEVICE NOT RETURNED FOR EXAMINATION, THE ROOT CAUSE OF THE PRODUCT COMPLAINT CANNOT BE DETERMINED. A REVIEW OF THE PRODUCT DHR SHOWED THAT ALL INSPECTIONS MET DESIGN SPECIFICATIONS. A REVIEW OF NCMR DATABASES DID NOT REVEAL ANY NONCONFORMANCE'S RELATED TO THIS INVESTIGATION.

    Additional Manufacturer Narrative · 0

    DEVICE IS NOT RETURNING FOR INVESTIGATION. REP STATED THAT THE TWO INFERIOR SCREWS FAILED LOCKING MECHANISM WAS REMOVED AND THEN DISCARDED PER BANNER POLICY. THE 4-LEVEL PLATE ASSEMBLY (PN:19-0478 LN: E12) WAS NOT RETURNED FOR INVESTIGATION. HOWEVER, BASED ON THE X-RAY IMAGE PROVIDED IT CAN BE CONFIRMED THAT A SCREW IS BACKING OUT AND THE LOCKING TAB HAS PULLED AWAY FROM THE PLATE. IT IS POSSIBLE THE LOCKING TAB COULD HAVE BEEN SUBJECTED TO OVERLOAD BY LEAVING THE SCREWS PROUD CAUSING THE LOCKING TAB TO STRESS AT FILLET WHICH IS A WEAKER CROSS SECTION OF THE DESIGN. HOWEVER, WITH THE LIMITED AVAILABLE INFORMATION AND THE DEVICE NOT RETURNED FOR EXAMINATION, THE ROOT CAUSE OF THE PRODUCT COMPLAINT CANNOT BE DETERMINED. A REVIEW OF THE PRODUCT DHR SHOWED THAT ALL INSPECTIONS MET DESIGN SPECIFICATIONS. A REVIEW OF NCMR DATABASES DID NOT REVEAL ANY NONCONFORMANCE'S RELATED TO THIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WENT IN FOR A 6 WEEK FOLLOW UP. PATIENT HARDWARE WAS INTACT. AT 4 MONTHS A LOCKING MECHANISM FAILED. TWO INFERIOR SCREWS AND FAILED LOCKING MECHANISM WERE REMOVED AND DISCARDED PER (B)(6) HOSPITAL POLICY. DEVICE NOT RETURNING. A REVISION WAS PERFORMED ON (B)(6) 2024. NO KNOWN NON-UNION. NO ISSUES INTRAOPERATIVELY. PATIENT HAD NO FALL OR ANY ACUTE INJURY. REV. 1 CORRECT COMPONENT CODE TO 907 PLATE (00016).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WENT IN FOR A 6 WEEK FOLLOW UP. PATIENT HARDWARE WAS INTACT. AT 4 MONTHS A LOCKING MECHANISM FAILED. TWO INFERIOR SCREWS AND FAILED LOCKING MECHANISM WERE REMOVED AND DISCARDED PER BANNER HOSPITAL POLICY. DEVICE NOT RETURNING. A REVISION WAS PERFORMED ON (B)(6) 2024. NO KNOWN NON-UNION. NO ISSUES INTRAOPERATIVELY. PATIENT HAD NO FALL OR ANY ACCUTE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1346797 CETRA 4-LEVEL PLATE ASSEMBLY, 78MM KWQ ORTHOFIX 19-0478 18257200120680

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other