BEUDAMED
    FDA Adverse Event Death Summary report: N

    INDUCTIGRAFT

    MDR report key: 5101358 · Received September 24, 2015

    Report

    Report Number
    1416980-2015-37113
    Event Type
    Death
    Date Received
    September 24, 2015
    Report Date
    December 2, 2015
    Manufacturer
    BAXTER APATECH LTD
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). ADDITIONAL INFORMATION: IT WAS REPORTED THAT DURING AN ANTERIOR LUMBAR INTERBODY FUSION THROUGH A TRANS-ABDOMINAL RETROPERITONEAL APPROACH, INDUCTIGRAFT PACK SIZE: 10ML WAS USED TO FILL UP THE LUMBAR CAGES (PREVIOUSLY REPORTED AS 5 TO 10 CC OF ACTIFUSE). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT ON AN UNCONFIRMED DATE APPROXIMATELY 6-7 WEEKS AGO ACTIFUSE ABX WAS USED. (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A PELVIC ABSCESS AND SUBSEQUENTLY PASSED AWAY AFTER USING 5 TO 10 CC OF ACTIFUSE. IT WAS REPORTED THAT DURING AN ANTERIOR LUMBAR INTERBODY FUSION THROUGH A TRANS-ABDOMINAL RETROPERITONEAL APPROACH, ACTIFUSE WAS USED TO FILL UP THE LUMBAR CAGES. NO COMPLICATIONS WERE NOTED DURING OR AFTER SURGERY, AND THE PATIENT WAS DISCHARGED ON POSTOPERATIVE DAY SIX. IT WAS REPORTED THAT SIX WEEKS POSTOPERATIVELY, WITHOUT ANY PRIOR SYMPTOMS, THE PATIENT COLLAPSED AND PASSED AWAY SHORTLY AFTER. THE CAUSE OF DEATH WAS REPORTED TO BE DUE TO A PELVIC ABSCESS. THE CAUSE OF THE ABSCESS WAS NOT REPORTED. AN AUTOPSY WAS PERFORMED AND A BLOODY, CLOUDY LIQUID CONTENT PELVIC HEMATOMA WAS DETECTED AND CONFIRMED TO BE SEPTIC. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633674 INDUCTIGRAFT FILLER, BONE VOID, CALCIUM COMPOUND MQV BAXTER APATECH LTD ELN83H040ZP

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death| H