BEUDAMED
    FDA Adverse Event Death Summary report: N

    NANOSS ADVANCED BONE GRAFT SUBSTITUTE

    MDR report key: 19809795 · Received July 23, 2024

    Report

    Report Number
    3009336436-2024-00001
    Event Type
    Death
    Date Received
    July 23, 2024
    Date of Event
    June 25, 2024
    Report Date
    July 19, 2024
    Manufacturer
    XTANT MEDICAL, INC.
    Product Code
    MQV
    UDI-DI
    00846468049461
    PMA / PMN Number
    K141600
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE COMPLAINT. THE DEVICE REMAINS IN PATEINT AND IS NOT AVAILABLE FOR INVESTIGATION. THIS REPORT WILL BE UPDATED SHOULD THIS INFORMATION BECOME AVAILABLE AT A LATER DATE. BATCH RECORD REVIEW WAS PERFORMED ON THE ASSOCIATED LOT AND DID NOT PRODUCE ANY NOTABLE FINDINGS. A RISK LINE COULD NOT BE IDENTIFIED BECAUSE IT IS UNKNOWN WHAT RELATION THE DEVICE INVOLVED MAY HAVE HAD TO THE REPORTED HARM; AS A RESULT, IT CANNOT BE DETERMINED WHAT HAZARD(S) OR SEQUENCE OF EVENTS MAY HAVE PRODUCED THE HAZARDOUS SITUATION THAT LED TO THE OBSERVED HARM. THOUGH INFREQUENT, CARDIAC ARREST IS A KNOWN COMPLICATION OF SPINAL SURGERY. AS DOCUMENTED IN THE IFU FOR THE DEVICE SYSTEM "ONE OF THE POTENTIAL RISKS IDENTIFIED WITH ANY SURGICAL PROCEDURE IS DEATH". THERE HAVE BEEN NO OTHER COMPLAINTS OF SIMILAR NATURE REPORTED TO THE MANUFACTURER OVER THE DEVICE DISTRIBUTION HISTORY. THE MANUFACTURER WILL CONTINUE TO MONITOR THIS PRODUCT FAMILY FOR COMPLAINTS FROM THE FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL FOUR (4) LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE AT C3 TO C7 USING TWO ANTERIOR INTERBODIES AND AN ANTERIOR PLATE SYSTEM AND A POSTERIOR CERVICAL FIXATION FROM C3 TO C7 USING A COMPETITOR POSTERIOR INTERBODY AND SCREW SYSTEM. DURING THE PROCEDURE, AFTER THE ANTERIOR PORTION OF THE PROCEDURE WAS COMPLETED AND DURING CLOSURE OF THE ANTERIOR SITE, IT WAS NOTED THAT THE PATIENT CODED AND WAS ABLE TO BE REVIVED. SUBSEQUENTLY, WHILE IN THE PROCESS OF FLIPPING THE PATIENT FROM ANTERIOR TO POSTERIOR, APPROXIMATELY 10 MINUTES AFTER CLOSURE OF THE ANTERIOR SITE, THE PATIENT SUFFERED A CARDIAC ARREST AND WAS UNABLE TO BE REVIVED. IT WAS BELIEVED THAT THE PATIENT MAY HAVE EXPERIENCED A PULMONARY EMBOLUS DURING THE FLIP MANEUVER. NO COMPLICATIONS WERE NOTED DURING THE ANTERIOR PORTION OF THE PROCEDURE. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2483210 NANOSS ADVANCED BONE GRAFT SUBSTITUTE BONE VOID FILLER MQV XTANT MEDICAL, INC. 90-100-10 433928 00846468049461

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Death 27-40 -FSD-14 4.0 X 14MM FSD SCREW| 27-40-FSD-16 4.0 X 16MM FSD SCREW| 27-45-FST-14 4.5 X 14MM FSD SCREW| 27-460 4 LEVEL 60MM PLATE| 27-MODDRILL-12 12MM DRILL BIT| 27-PUSHPIN STAY PIN| 65-C-1517-7-6L 15 X 17 X 7MM 6* SPACER| 65-C-1517-8-6L 15 X17 X 8MM 6* SPACER