BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAMBA 3D FIREBIRD SI FUSION

    MDR report key: 19437581 · Received May 31, 2024

    Report

    Report Number
    2183449-2024-00006
    Event Type
    Injury
    Date Received
    May 31, 2024
    Date of Event
    April 15, 2024
    Report Date
    May 31, 2024
    Manufacturer
    ORTHOFIX
    Product Code
    HWC
    PMA / PMN Number
    K121148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SHORT STEINMANN PIN (PN:18-3105 LN: UNK) WAS NOT RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE INJURY OCCURRED EITHER DURING STEINMANN PIN (18-3105) PLACEMENT OR DURING TISSUE DISSECTION (18-3008). HOWEVER, IT WAS SAID THAT HERE WERE NO DEFECTS ATTRIBUTED TO THESE INSTRUMENTS AND THE INJURY COULD HAVE OCCURRED DUE TO ANATOMICAL ANOMALIES OR INACCURATE TARGETING. THIS IS A KNOWN RISK OF THE PROCEDURE DUE TO THE ANATOMY INVOLVED. THE REP ALSO REPORTED THAT THE SCREWS WERE REMOVED, AND RESCUE SCREWS (12MM) IMPLANTED. NOTHING WILL BE SENT BACK AS NOTHING WITH THE IMPLANTS THEMSELVES CAUSED THE ISSUE. THE REVISION SURGERY WAS ON MAY 7TH. RADIOGRAPHIC IMAGING WAS NOT PROVIDED FOR REVIEW. WITH THE LIMITED INFORMATION PROVIDED, IT IS NOT POSSIBLE TO CONFIRM THE FAILURE REPORTED AND DETERMINE A ROOT CAUSE. SHOULD ORTHOFIX RECEIVE ADDITIONAL INFORMATION REGARDING THIS INCIDENT, THE COMPLAINT WILL BE RE-OPENED FOR INVESTIGATION. WITHOUT A LOT NUMBER, A REVIEW OF THE DHR AND NCMR DATABASE CANNOT BE COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALE PATIENT RETURNED POST-OP WITH AN INFECTION FROM A PROCEDURE DONE ON (B)(6) 2024. THE PATIENT EXPERIENCED A VASCULAR INJURY DURING SURGERY WHICH RESULTED IN A TRIP TO THE ER. THE PATIENT PRESENTED WITH AN ANATOMICAL ANOMALY WHICH IS MORE THAN LIKELY THE CAUSE AND NOT NECESSARILY ATTRIBUTED TO THE SYSTEM. THE INJURY HAPPENED DURING STEINMANN PIN (18-3105) PLACEMENT OR DURING TISSUE DISSECTION (18-3008). PATIENT WAS BEING TREATED FOR BIFURCATION OF THE SUPERIOR GLUTEAL ARTERY. SURGERY DESCRIPTION WAS AN SI FUSION. THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312149 SAMBA 3D FIREBIRD SI FUSION SHARP, SHORT STEINMANN PIN HWC ORTHOFIX 18-3015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other