BEUDAMED
    FDA Adverse Event Death Summary report: N

    2.5MM TI CANN SCREW + ST - 26MM

    MDR report key: 19059941 · Received April 8, 2024

    Report

    Report Number
    3012966183-2024-00007
    Event Type
    Death
    Date Received
    April 8, 2024
    Date of Event
    July 24, 2023
    Report Date
    April 12, 2024
    Manufacturer
    TYBER MEDICAL
    Product Code
    HWC
    UDI-DI
    00810040630774
    PMA / PMN Number
    K192975
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ADVERSE EVENT CLINICAL SURGEON ((B)(6)) STATED THAT THE CAUSE OF DEATH IS NOT RELATED TO THE STUDY DEVICE OR SURGICAL PROCEDURE.

    Description of Event or Problem · 0

    UPDATED AFTER FURTHER INVESTIGATION, PROVIDED BY USER FACILITY: PATIENT PRESENTED TO ED WITH A RIGHT TRI MALLEOLAR ANKLE FRACTURE & LARGE POSTERIOR FRAGMENT WHICH OCCURRED DURING AN MVA. PATIENT WAS STABLE AND RECEIVED MEDICAL CLEARANCE PRIOR TO PROCEEDING WITH SURGERY. POSTERIOR MALLEOLUS FRACTURE WAS ADDRESSED FIRST WHICH WAS REDUCED AND PLATED IN AN ANTI-GLIDE TECHNIQUE WITH A SYNTHES POSTERIOR PLATE. THE FIBULA WAS THEN PLATED USING A SYNTHES FIBULAR PLATE, ALIGNMENT AND LENGTH WERE MAINTAINED. SECOND INCISION OVER THE MEDIAL MALLEOLUS WAS MADE WHERE 2 2.5MM SYNTHES CANNULATED SCREWS WERE PLACED TO FIX THE ANTERIOR COLLICULUS FRAGMENT. AFTER ADDRESSING THE FRACTURES, REPAIR WAS CONFIRMED ON FLUOROSCOPIC IMAGING AND ALL WOUNDS WERE IRRIGATED AND HAD VANCOMYCIN POWDER PLACED IN THEM. PATIENT WAS PLACED IN A SUGAR TONG SPLINT AND WAS TRANSFERRED TO PACU AFTER SURGERY IN STABLE CONDITION. THERE WERE NO SURGICAL DELAYS OR CHANGES FROM PRE-OP INDICATION FOR SURGERY. STRATEGY AND APPROACH FOR SURGERY STAYED THE SAME THROUGHOUT. ALL FRACTURE SITES WERE CLEARLY INDICATED ON PREOP IMAGING. PATIENT'S POST-OP BEHAVIOR WAS NORMAL. PROPER PAIN MANAGEMENT AND DVT PROPHYLAXIS WAS PROVIDED. DISCHARGED FROM HOSPITAL 2 DAYS POST-OP TO REHAB FACILITY WITH CLEARANCE FROM ORTHO & HOSPITALIST. ALL IMPLANTS WERE USED FOR ON LABEL INDICATED USE OF FRACTURE REPAIR. PER NOTE IN EMR, PATIENT FOUND UNRESPONSIVE IN BED AT REHAB FACILITY. FAILED TO RESUSCITATE PATIENT, CAUSE OF DEATH DEEMED TO BE NATURAL.

    Description of Event or Problem · 0

    RETROSPECTIVE CLINICAL STUDY: PATIENT PASSED AWAY UNEXPECTEDLY IN HER HOME 11 DAYS POST OPERATIVE. THE ADVERSE EVENT FORM STATES THIS WAS NOT IN RELATION TO THE STUDY DEVICE OR THE SURGICAL PROCEDURE, BUT THE ACTUAL CAUSE OF DEATH WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412639 2.5MM TI CANN SCREW + ST - 26MM 2.5MM TITANIUM CANNULATED HEADED SCREW - 26MM HWC TYBER MEDICAL 04.353.126 00810040630774

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Death SYNTHES FIBULAR PLATE.| SYNTHES POSTERIOR PLATE.