BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIFUSE BONE GRAFT SUBSTITUTE

    MDR report key: 2631564 · Received June 27, 2012

    Report

    Report Number
    3004450973-2012-00013
    Event Type
    Injury
    Date Received
    June 27, 2012
    Date of Event
    May 21, 2012
    Report Date
    June 13, 2012
    Manufacturer
    BAXTER APATECH LTD
    Product Code
    MQV
    PMA / PMN Number
    K081979
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER FINAL MEDICAL ASSESSMENT: THIS IS STUDY (B)(4), (B)(6) WHERE PRIOR TO (B)(6) 2011, THE PATIENT UNDERWENT POSTERIOLATERAL FUSION WHEN ACTIFUSE ABX WAS USED. ON (B)(6) 2011, THE PATIENT COMPLAINED OF CONTINUING PAIN IN BOTH LEGS, BURNING AND CRAMPING, FOR WHICH HE UNDERWENT INSERTION OF AN EPIDERMAL SPINAL ELECTRO STIMULATION CATHETER. THE COMPLAINT WAS COMPLETED RESOLVED BY (B)(6) 2011. THIS SAME PATIENT WAS READMITTED ON (B)(6) 2012, FOR REPLACEMENT OF THE EPIDERMAL SPINAL ELECTRO STIMULATION CATHETER. THERE IS NO DESCRIPTION OF WHAT SYMPTOMS THE PATIENT WAS COMPLAINING OF, HOWEVER RETURN OF LEG PAIN IS THE MOST OBVIOUS. WHATEVER THE SYMPTOMS, THEY WERE RESOLVED WITH REPLACEMENT OF THE CATHETER ON (B)(6) 2012. GIVEN THE LEG PAIN CONTINUED DESPITE PLF SURGERY WHERE ACTIFUSE ABX WAS USED, BUT DID NOT WORSEN, THE USE OF ACTIFUSE ABX IS UNLIKELY TO HAVE CAUSED OR CONTRIBUTED TO THIS PATIENT'S CONTINUED LEG PAIN. THE RETURN OF SYMPTOMS ONE YEAR LATER WHERE REPLACEMENT OF THE ELECTRO STIMULATION CATHETER RESOLVED THE SYMPTOMS WITHIN 24 HOURS OF IMPLANT WOULD ALSO SUGGEST NO CAUSAL RELATIONSHIP TO THE PREVIOUS USE OF ACTIFUSE ABX. THE EVENT IS NOT RELATED TO ACTIFUSE.

    Additional Manufacturer Narrative · 1

    (B)(4). DUE TO THE LACK OF INFORMATION, THIS CASE IS BEING CONSERVATIVELY REPORTED. BAXTER IS CURRENTLY IN THE PROCESS OF 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

    ONSET DATE: (B)(6) 2012, (B)(6) - CATHETER CHANGED. THE PATIENT REQUIRED HOSPITALIZATION/PROLONGATION OF EXISTING HOSPITALIZATION. THE EVENT IS UNRESOLVED. NO MEDICATION HAS BEEN ADMINISTERED, AND NO PROCEDURE HAS BEEN PERFORMED AS TREATMENT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: ESES STANDS FOR EPIDURAL SPINAL ELECTRO STIMULATION (ALSO CALLED SCS). THE ESES WAS FIRST IMPLANTED IN (B)(6) 2011. THE DEVICE WAS REPLACED BECAUSE THE PATIENT HAD COMPLAINTS ABOUT IT AND THIS REPLACEMENT WAS THE REASON FOR A NEW SAE REPORT. THE PATIENT EXPERIENCED CONTINUED PAIN IN BOTH LEGS, BURNING/CRAMPING AFTER REVISION PEDICLE-SCREWS, RIGHT SIDE. THE ISSUE RESOLVED ON (B)(6) 2011.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other