BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIFUSE BONE GRAFT SUBSTITUTE

    MDR report key: 3173762 · Received June 17, 2013

    Report

    Report Number
    3004450973-2013-00007
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BAXTER APATECH LTD
    Product Code
    MQV
    PMA / PMN Number
    K082575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: ACTIFUSE ABX HAS BEEN USED FOR AN INSTRUMENTED SPINAL FUSION AND PRODUCT MIGRATED INTO SURROUNDING TISSUE CAUSING SPINAL ROOT IRRITATION (RADICULITIS). THIS COMPLICATION REQUIRED RE-INTERVENTION WITH MATERIAL REMOVAL AND NERVE ROOT DECOMPRESSION. MIGRATION OF THE SILICATED CALCIUM TRIPHOSPHATE GRANULES MAY OCCUR WHERE ACTIFUSE IS BEENG SUBJECTED TO TENSION, TORSION, COMPRESSION, SHEAR OR BENDING. A CONVENTIONAL IMPLANT (E.G., CAGE) CAN PROTECT THE GRAFT FROM SUCH LOADING ACTIONS. ALTERNATIVELY MIGRATION OF ACTIFUSE PARTICLES MAY POTENTIALLY OCCUR WHEN USED IN VOLUMETRICALLY UNCONSTRAINED SITES (SO THE GRAFT MATERIAL CANNOT MOVE OR ESCAPE), OR DUE TO FAST RESORBTION OF THE AQUEOUS CARRIER. ALTERNATIVE PROCEDURE,-, PATIENT-, AND PATHOLOGY-RELATED CAUSES ARE TO BE CONSIDERED (INFLAMMATORY REACTION OF THE ROOT, EXOSTOSIS/HYPEROSTOSIS, INSTRUMENTATION FAILURE/MOBILITY OF INSTRUMENTED SEGMENT, ETC.) ALTHOUGH THE REPORTING SURGEON IS REFERRING TO A "MINOR INJURY" THE INCIDENT REQUIRED A SURGICAL INTERVENTION, WHICH QUALIFIES AS SERIOUS INJURY (ACC. TO REPORTING REGULATIONS). WE CANNOT RULE OUT THAT THE SERIOUS ADVERSE EVENT IS RELATED TO THE USE OF ACTIFUSE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER APATECH COMPLETED THE INVESTIGATION. SAMPLE EVALUATION AND BATCH REVIEW COULD NOT BE PERFORMED AS NO SAMPLE AND LOT NUMBER WERE PROVIDED. NO TREND WAS IDENTIFIED. BAXTER APATECH HAS CAPTURED THIS EVENT AS A POST MARKET SURVEILLANCE ACTION AND IT IS INCLUDED IN THE RISK MANAGEMENT FILE. THE MANUFACTURING FACILITY DETERMINED NO FURTHER INVESTIGATION IS POSSIBLE AS PRODUCT LOT NUMBER AND SAMPLE ARE NOT AVAILABLE. THE CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    UPON OBTAINING ADDITIONAL INFORMATION FOR A PREVIOUS REPORTED CASE, THE REPORTING SURGEON STATED FOUR (4) PATIENTS WERE INVOLVED NOT ONLY THREE (3). THIS COMPLAINT REFLECTS THE 4TH PATIENT'S CASE. PLEASE REFER BELOW TO THE CASES REPORTED PREVIOUSLY: BAXTER REFERENCE CASE #(B)(4) (MDR#: 3004450973-2013-00004); BAXTER REFERENCE CASE #(B)(4) (MDR#: 3004450973-2013-00005); BAXTER REFERENCE CASE #(B)(4) (MDR#: 3004450973-2013-00006). BAXTER UK WAS ABLE TO OBTAIN THE FOLLOWING INFORMATION ON (B)(6) 2013, FOR THE NEW CASE: THE SURGEON REPORTED THAT A PATIENT EXPERIENCED GRAFT MIGRATION TO A PATIENT TREATED IN THE CERVICAL SPINE IN WHICH ACTIFUSE WAS USED. HE HAD USED 10-ML OF ACTIFUSE ABX ON EACH SIDE OF THE SPINE AT EACH LEVEL TO CREATE A BILATERAL POSTEROLATERAL FUSION. ACTIFUSE ABX WAS IMPLANTED BETWEEN OR EITHER SIDE (I.E. NOT ON TOP OF) THE RODS/SCREWS SO THAT IT WAS NOT ANY MORE SUPERIOR TO THE IMPLANTED METALWORK. ACTIFUSE ABX WAS NOT USED ANTERIORLY OR INSIDE THE INTERVERTEBRAL CAGE. THE PRODUCT WAS NOT MIXED WITH SALINE/BLOOD/BMA/LOCAL BONE. THE SURGEON OBSERVED NON-FUSION AT 6 MONTHS FOLLOW-UP. CLINICALLY THIS RESULTED IN A MILD STOOP FORWARD IN THE UPPER REGION OF THE NECK. THE SURGEON DID NOT EXPAND ON THE MINOR INJURY IN RELATION TO CLINICAL OUTCOMES. HE ALSO CONFIRMED THAT THE PATIENT WAS RE-OPERATED ON AND THAT WHEN HE PERFORMED THE SURGERY HE FOUND SOME GRANULES APPROXIMATELY 1CM UNDER THE LAYER OF SKIN ABOVE THE IMPLANTATION SITE. THE REPORTING SURGEON DID NOT QUANTIFY THE AMOUNT OF GRANULES FOUND. HE BELIEVED THE MIGRATION TO HAVE RESULTED FROM MOVEMENT OF THE OVERLYING MUSCLES PUSHING THE IMPLANTED GRANULES IN THE CAUDAL DIRECTION. THE RE-OPERATIONS WERE PERFORMED WITH AN ALTERNATIVE SYNTHETIC BONE GRAFT SUBSTITUTE. THE RE-OPERATION WAS SUCCESSFUL AT THE TIME OF THE MEETING. THE SURGEON WAS ABLE TO PROVIDE EVIDENCE IN THE FORM OF A CT SCAN THAT THE ACTIFUSE ABX HAD MIGRATED CAUDALLY FROM THE C1-C2 REGION. THE SURGEON WAS NOT PREPARED TO PROVIDE THE CT'S AS HE DID NOT HAVE PATIENT CONSENT TO SHARE THE DATA. CUSTOMER DOES NOT HAVE THE SAMPLE OR LOT NUMBER. DATES WERE NOT PROVIDED BUT ESTIMATED TO BE BETWEEN 6-18 MONTHS AGO FROM THE MEETING DATE. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273913 ACTIFUSE BONE GRAFT SUBSTITUTE FILLER, BONE VOID, CALCIUM COMPOUND MQV BAXTER APATECH LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other