BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORTOSS MIX TIPS TAP

    MDR report key: 8462818 · Received March 28, 2019

    Report

    Report Number
    0002530131-2019-00001
    Event Type
    Death
    Date Received
    March 28, 2019
    Date of Event
    March 1, 2019
    Report Date
    May 9, 2019
    Manufacturer
    STRYKER SPINE-US
    Product Code
    NDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    METHOD: LABELING REVIEW, MEDICAL ASSESSMENT, RISK ASSESSMENT. RESULTS: ON (B)(6), THE SALES REPRESENTATIVE BECAME AWARE THAT THE PATIENT HAD PASSED TWO WEEKS AFTER THE PROCEDURE. THE EVENT WAS INVESTIGATED AND CONCLUDED THE FOLLOWING: THERE WAS NO CORTOSS LEAKAGE DURING THE INJECTION. THE MATERIAL WAS NOT OVERFILLED OR INJECTED TOO QUICKLY, THE MIX TIP WAS PUSHED IN AFTER ALIGNING THE NOTCHES AND WAS PROPERLY ROTATED CLOCKWISE UNTIL THE MECHANICAL STOP WAS REACHED, THE PRODUCT WAS ALLOWED TO EQUILIBRATE TO ROOM TEMPERATURE PRIOR TO USE 1-1.5HOUR WHICH ALIGNS WITH THE LABELLING IN THE SURGICAL TECHNIQUE. THE MATERIAL REMAINS IMPLANTED IN THE PATIENT. UPON FOLLOW UP WITH THE SALES REPRESENTATIVE, IT WAS REPORTED THAT THE HOSPITAL AND SURGEON WHO PERFORMED THE SURGERY, DO NOT BELIEVE DEATH IS PRODUCT RELATED. IT WAS DISCOVERED THAT THE PATIENT WAS PREVIOUSLY DIAGNOSED WITH PNEUMONIA AND DID NOT INFORM THE SURGEON OR THE STAFF OF THIS PRE-EXISTING CONDITION. THE PATIENT WAS REPORTED TO HAVE BEEN IN A LOT OF PAIN AND WANTED THE TREATMENT, THUS FAILING TO DISCLOSE PNEUMONIA. THE PATIENT REMAINED IN THE INTENSIVE CARE UNIT AFTER THE PROCEDURE, AND EVENTUALLY DEVELOPED SEPSIS. THE EVENT WAS ASSESSED BY A MEDICAL PROFESSIONAL WHO DOES NOT BELIEVE THAT 0.1CC OF CORTOSS WOULD CAUSE ANY SYSTEMIC COMPLICATIONS. SEPSIS WAS MOST LIKELY DEVELOPED EITHER DUE TO INHERENT RISK OF INFECTION ASSOCIATED WITH SURGICAL PROCEDURES OR DUE TO THE PATIENT¿S ICU STAY. CONCLUSION: BASED ON THE INFORMATION PROVIDED, THIS EVENT IS NOT PRODUCT RELATED. THE ROOT CAUSE OF THE REPORTED EVENT IS PATIENT 'S PRE-EXISTING CONDITIONS WHICH WERE NOT DISCLOSED TO THE SURGEON PRIOR TO THE SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AS THE DR WAS INJECTING CORTOSS, PATIENT DEVELOPED DIFFICULTY BREATHING. THE ACCESS CANNULA AND VERTEPORT WERE REMOVED. MEDICAL INTERVENTION- CHEST COMPRESSIONS AND INTUBATION WERE DELIVERED TO THE PATIENT. PER THE COMMUNICATION DETAILS, THE SALES REPRESENTATIVE REPORTED THAT THE EVENT WAS NOT PRODUCT RELATED AND THAT THE PATIENT HAD PNEUMONIA BUT CHOSE NOT TO DISCLOSE THIS INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS THE DR WAS INJECTING CORTOSS, PATIENT DEVELOPED DIFFICULTY BREATHING. THE ACCESS CANNULA AND VERTEPORT WERE REMOVED. MEDICAL INTERVENTION- CHEST COMPRESSIONS AND INTUBATION WERE DELIVERED TO THE PATIENT. PER THE COMMUNICATION DETAILS, THE SALES REPRESENTATIVE REPORTED THAT THE EVENT WAS NOT PRODUCT RELATED AND THAT THE PATIENT HAD PNEUMONIA BUT CHOSE NOT TO DISCLOSE THIS INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255961 CORTOSS MIX TIPS TAP POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT NDN STRYKER SPINE-US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention