BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASPECT ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 19781925 · Received July 19, 2024

    Report

    Report Number
    3005031160-2024-00026
    Event Type
    Death
    Date Received
    July 19, 2024
    Date of Event
    June 25, 2024
    Report Date
    July 19, 2024
    Manufacturer
    XTANT MEDICAL HOLDINGS, INC
    Product Code
    KWQ
    PMA / PMN Number
    K130427
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: IT IS UNKNOWN WHAT SYSTEM DEVICE MAY HAVE BEEN A FACTOR IN THE REPORTED EVENT: [MODEL# 27-460; LOT# UNK; UDI (B)(4), [MODEL# 27-40-FSD-14; LOT# UNK; UDI (B)(4], [MODEL# 27-40-FSD-16; LOT# UNK; UDI (B)(4), [MODEL# 27-45-FST-14; LOT# UNK; UDI (B)(4), [MODEL# 27-MODDRILL-12; LOT# UNK; UDI (B)(4)], AND [MODEL# 27-PUSHPIN; LOT# UNK; UDI (B)(4)]. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE COMPLAINANT. NO PRODUCT EVALUATION WAS ABLE TO BE PERFORMED AS THE DEVICES INVOLVED WERE NOT AVAILABLE FOR INVESTIGATION; FURTHER, THERE WAS NO PRODUCT FAILURE ALLEGED AS A PART OF THE REPORTED EVENT. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A REVIEW OF MANUFACTURING RECORDS WAS UNABLE TO BE PERFORMED FOR AS THE LOT INFORMATION OF THE POSSIBLE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE. IT IS UNKNOWN WHAT RELATION THE DEVICE(S) INVOLVED MAY HAVE HAD TO THE REPORTED ADVERSE EVENT; 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. NO FURTHER INVESTIGATION WAS ABLE TO BE COMPLETED AT THIS TIME. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED WITH THE INFORMATION PROVIDED. AS DOCUMENTED IN THE IFU FOR THE DEVICE SYSTEM "ONE OF THE POTENTIAL RISKS IDENTIFIED WITH ANY SURGICAL PROCEDURE IS DEATH". FURTHER "ONLY EXPERIENCED SPINE SURGEONS SHOULD PERFORM THE IMPLANTATION OF ANTERIOR CERVICAL SPINAL SYSTEMS WITH SPECIFIC TRAINING IN THE USE OF THIS SPINAL SYSTEM. THIS IS A TECHNICALLY DEMANDING PROCEDURE PRESENTING A RISK OF SERIOUS INJURY TO THE PATIENT. PREOPERATIVE PLANNING AND PATIENT ANATOMY SHOULD BE CONSIDERED WHEN SELECTING CERVICAL SCREW DIAMETER AND LENGTH". IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    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
    1466303 ASPECT ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ XTANT MEDICAL HOLDINGS, INC SEE H11 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Death 65-C-1517-7-6L ANTERIOR CAGE| 65-C-1517-8-6L ANTERIOR CAGE| 90-100-10 BONE VOID FILLER