BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN RODS

    MDR report key: 12010307 · Received June 16, 2021

    Report

    Report Number
    1526439-2021-01227
    Event Type
    Death
    Date Received
    June 16, 2021
    Date of Event
    May 21, 2021
    Report Date
    May 21, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME, PROCODE, MANUFACTURER NAME, CITY AND STATE, SERIAL #, PMA/510K: THIS REPORT IS FOR AN UNKNOWN RODS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE EVALUATED BY MFR, DEVICE MANUFACTURE DATE: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT SURGERY FOR LEVEL 4 STABILIZATION OF AN ANKYLOSING SPONDYLITIS USING VIPER CORTICAL FIX FENESTRATED SCREWS AND CONFIDENCE CEMENT. THE SURGEON USED FENESTRATED SCREWS IN THE PATIENT BONE BUT STATED BONE QUALITY WAS NOT GOOD AND ELECTED TO AUGMENT WITH CONFIDENCE CEMENT. THE SURGEON USED TWO (2) BOXES OF CEMENT. A THIRD BOX WAS OPENED BUT WAS NOT USED DUE TO CHANGE IN PATIENT BLOOD PRESSURE. THE PATIENT WAS IMPLANTED WITH THE FIRST ROD SUCCESSFULLY BUT DURING THE SECOND ROD INSERTION THE PATIENT IS BELIEVED TO HAVE GONE INTO CARDIAC ARREST. THE PATIENT WAS IMPLANTED WITH EIGHT SCREWS BUT ONE WAS NOT TIGHTENED IN THE FINAL RUSH TO REMOVE INSTRUMENTATION AT THE END OF THE CASE. TOWARD THE END OF THE PROCEDURE, THE ANESTHETIST NOTIFIED THE SURGEON THAT THE PROCEDURE HAD TO BE HALTED IMMEDIATELY DUE TO CHANGE IN BLOOD PRESSURE. THE PATIENT PASSED AWAY ON THE TABLE SOON AFTER. THERE IS NO ALLEGATION AGAINST THE DEVICES THAT WERE IN USE. THE SURGEON WAS USING THE FOLLOWING DEVICES FOR THE PROCEDURE: EIGHT UNKNOWN SCREWS, EIGHT UNKNOWN LOCKING/SET SCREWS, TWO UNKNOWN RODS, THREE UNKNOWN BIOMATERIAL-CEMENT, TWO UNKNOWN ATTACHMENTS, AND THREE UNKNOWN BIOMATERIAL- CEMENT DELIVERY DEVICES. THIS REPORT IS FOR ONE (1) UNKNOWN RODS. THIS IS REPORT 3 OF 26 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904353 UNKNOWN RODS ROD, FIXATION, INTRAMEDULLARY HSB MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Death