BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIREBIRD SFS

    MDR report key: 18257350 · Received December 4, 2023

    Report

    Report Number
    2183449-2023-00006
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    November 15, 2023
    Report Date
    April 1, 2024
    Manufacturer
    ORTHOFIX MEDICAL INC
    Product Code
    NKB
    UDI-DI
    18257200113545
    PMA / PMN Number
    K081684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED AND IS CURRENTLY PENDING EVALUATION.

    Description of Event or Problem · 0

    INFORMATION PROVIDED STATES THAT THE PATIENT HAD SPINE FIXATION SURGERY IN (B)(6) 2023. X-RAY IMAGES TAKEN IN (B)(6) SHOW A BROKEN BONE SCREW. A REVISION SURGERY WAS PERFORMED TO REMOVE/REPLACE THE BROKEN SCREW.

    Description of Event or Problem · 0

    THE DEVICE WAS RETURNED FOR INVESTIGATION. NO NCMRS WERE ASSOCIATED WITH THIS LOT OR FAILURE REPORTED. WITHOUT THE LN OF THE SCREW, A REVIEW OF THE DHR AND NCMR DATABASE COULD NOT BE COMPLETED. THE 5.5X45MM MODULAR BONE SCREW AND TOP LOADING BODY (PN: 44-5545 AND 36-2101, LN: UNK AND O65) WERE RETURNED FOR INVESTIGATION. INFORMATION PROVIDED STATED THAT THERE WAS AN INCIDENT INVOLVING A FIREBIRD SCREW FROM A SURGERY DONE IN FEBRUARY. INSPECTION OF THE RETURNED PRODUCT CONFIRMED THE SCREW WAS BROKEN AND THE HEAD OF THE SCREW WAS JAMMED IN THE TOP LOADING BODY. NUMEROUS ATTEMPTS WERE MADE TO GATHER NECESSARY ADDITIONAL INFORMATION WITHOUT SUCCESS. WITHOUT ADDITIONAL RADIOGRAPHIC IMAGES, IT WAS NOT POSSIBLE TO ASSESS THE POTENTIAL ROLE OF SURGICAL TECHNIQUE OR PATIENT SELECTION. BASED ON THE LIMITED INFORMATION PROVIDED, IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE OF THIS REPORTED FAILURE. THIS IS THE 1ST OCCURRENCE OF THIS REPORTED FAILURE MODE FOR PN: 44-5545 IN THE PAST 2 YEARS OUT OF APPROXIMATELY (B)(4) UNITS SOLD. THE ESTIMATED OCCURRENCE RATE IS (B)(4), WHICH CORRESPONDS TO A LEVEL 2 (REMOTE). THIS IS THE 1ST OCCURRENCE OF THIS REPORTED FAILURE MODE FOR PN: 36-2101 IN THE PAST 2 YEARS OUT OF APPROXIMATELY (B)(4) UNITS SOLD. THE ESTIMATED OCCURRENCE RATE IS (B)(4), WHICH CORRESPONDS TO A LEVEL 1 (IMPROBABLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1593535 FIREBIRD SFS PEDICAL SCREW, MODULAR NKB ORTHOFIX MEDICAL INC 18257200113545

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other