BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIFUSE (ABX E-Z-FIL PUTTY)

    MDR report key: 3533344 · Received December 23, 2013

    Report

    Report Number
    2032282-2013-00170
    Event Type
    Injury
    Date Received
    December 23, 2013
    Date of Event
    October 18, 2013
    Report Date
    December 12, 2013
    Manufacturer
    BAXTER APATECH LTD
    Product Code
    MQV
    PMA / PMN Number
    K071206
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE REPORTER IN AN EFFORT TO RETRIEVE ADDITIONAL CASE INFORMATION. NO RESPONSE WAS RECEIVED. BAXTER (B)(4) COMPLETED THE INVESTIGATION. SAMPLE EVALUATION COULD NOT BE PERFORMED AS NO SAMPLE WAS PROVIDED. BATCH REVIEW WAS PERFORMED FOR THE REPORTED LOT AND IT WAS DETERMINED ALL RELEASE/TESTING SPECIFICATIONS WERE MET. NO TREND IDENTIFIED. PER (B)(4), A REVIEW OF DETAILS OF THE COMPLAINT AND MEDICAL ASSESSMENT INDICATED THAT NO FURTHER INVESTIGATION IS NECESSARY AS THE BATCH RECORD REVIEW CONFIRMED THE PRODUCT LOT MET ALL RELEASE SPECIFICATIONS. CUSTOMER CLOSURE LETTER WAS SENT NOTIFYING CLOSURE OF COMPLAINT AND REQUESTING A FINAL WRITTEN ATTEMPT FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, THE CASE WILL BE RE-OPENED AND RE-ASSESSED. THIS CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT SUMMARY: A CSF FISTULAS MAY OCCUR DUE TO AN INCIDENTAL DUROTOMY, DURING INTRADURAL SURGERY, OR FROM TRAUMA OR CONGENITAL ABNORMALITY. THE MAJORITY OF CSF FISTULAS ARE IATROGENIC AND OCCUR IN THE POSTERIOR LUMBAR REGION FOLLOWING SURGERY. SINCE IN THIS CASE A MIGRATION OF THE PRODUCT HAS BEEN DIAGNOSED DURING REVISION SURGERY (ACTIFUSE MIGRATED UNDER THE H-GRAFT BONE) WE CANNOT EXCLUDE THAT THE ASSOCIATED INFLAMMATORY REACTION AND THE PRODUCT MIGRATION IN THE VICINITY OF THE DURA MATER HAVE ULTIMATELY CONTRIBUTED TO THE FORMATION OF THE DURA DEFECT. THE POSSIBILITY OF A LOCAL INFLAMMATORY REACTION IS ALSO SUPPORTED BY THE PRESENCE OF A ¿FUSION¿ OF THE BONE SUBSTITUTE TO THE PARAVERTEBRAL MUSCLES. WE CANNOT EXCLUDE THAT ACTIFUSE CAUSED OR CONTRIBUTED TO THE REPORTED COMPLICATION. BAXTER IS STILL FOLLOWING UP WITH THE REPORTER FOR ADDITIONAL INFORMATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SAME CUSTOMER THAT ANOTHER PATIENT EXPERIENCED A COMPLICATION AFTER THE USE OF ACTIFUSE ABX. PREVIOUS CASES WERE REPORTED BELOW FROM THE SAME SURGEON: PATIENT#1: MDR#: 2032282-2013-00167 (PRODUCT LOT#: ELS80G091TP), MDR#: 2032282-2013-00168 (PRODUCT LOT#: ELS80G023OP), MDR#: 2032282-2013-00169 (PRODUCT LOT#: ELS80G023QP). PATIENT #2: MDR#: 2032282-2013-00162 (PRODUCT LOT#: ELS80G110LP), MDR#: 2032282-2013-00163 (PRODUCT LOT#: ELS80G134BP). PATIENT #3: MDR#: 2032282-2013-00164 (PRODUCT LOT#: ELS80G091TP), MDR#: 2032282-2013-00165 (PRODUCT LOT#: ELS80G110LP), MDR#: 2032282-2013-00166 (PRODUCT LOT#: ELS80G023OP). PATIENT 4 OF 4 (ELS80G134BP): PATIENT LAST NAME INITIAL: (B)(6), PRODUCT LOT#: ELS80G134BP AND ELS80G091TP, DATE OF INITIAL SURGERY: (B)(6) 2013. IT WAS REPORTED TO BAXTER THE SAME OPERATING SURGEON EXPERIENCED ANOTHER PATIENT WITH A CSF LEAK IN WHICH ACTIFUSE WAS USED DURING AN ILIF SURGERY ON (B)(6) 2013. THE PATIENT WILL BE TAKEN BACK TO THE OR FOR EXPLORATION ON (B)(6) 2013. NO FURTHER INFORMATION PROVIDED. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013: TODAY WE BROUGHT PATIENT "(B)(6)" BACK TO O.R. FOR EXPLORATION SURGERY. THE SURGEON FOUND THE ACTIFUSE ABX HAD MIGRATED UNDER THE H-GRAFT BONE AND ERODED THE DURA LEAVING A HUGE HOLE IN THE DURA....THE HOLE WAS ABOUT THE SIZE OF A DIME. IN ADDITION, THE ACTIFUSE HAS FUSED TO THE MUSCLE. THE SURGEON HAD TO USE A CURETTE TO SCRAPE IT OFF OF THE MUSCLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672060 ACTIFUSE (ABX E-Z-FIL PUTTY) FILLER, BONE VOID, CALCIUM COMPOUND MQV BAXTER APATECH LTD ELS80G134BP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other