BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES

    MDR report key: 3864382 · Received June 10, 2014

    Report

    Report Number
    2032282-2014-00079
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 29, 2014
    Manufacturer
    BAXTER APATECH LTD
    Product Code
    MQV
    PMA / PMN Number
    K082575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER (B)(4) COMPLETED THE INVESTIGATION. NO SAMPLE WAS RECEIVED FOR EVALUATION. BATCH RECORD REVIEW WAS PERFORMED AND IT WAS DETERMINED THE PRODUCT LOT NUMBER MET ALL RELEASE AND TESTING SPECIFICATIONS. NO TREND WAS IDENTIFIED. THIS IS THE FIRST REPORTED COMPLAINT OF THIS NATURE FOR THIS PRODUCT LOT. THIS COMPLAINT WILL BE KEPT ON RECORD FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: USE OF A PROPERLY LABELED PRODUCT BEYOND THE EXPIRATION DATE IS A USER ERROR. EXPIRED PRODUCT MAY POTENTIALLY HAVE A REDUCED THERAPEUTIC EFFECT (NO ADEQUATE BONE FORMATION) OR MAY LOSE ALSO ITS STERILITY. SINCE BONE HEALING AND FUSION OCCURS OVER MANY MONTHS, THE FINAL IMPACT OF THIS USER ERROR CANNOT BE JUDGED IN SHORT TERM. AFTER CONSIDERATION FOR POTENTIAL HARMS AND WORST-CASE SCENARIOS, WE CANNOT EXCLUDE THAT AN ADVERSE HEALTH CONSEQUENCE MAY OCCUR AS A RESULT FROM THIS USER ERROR (USE OVER EXPIRATION TIME). A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND COMPLETION OF MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM A DISTRIBUTOR THAT A DOCTOR AT (B)(6) IMPLANTED EXPIRED ACTIFUSE INTO A PATIENT ON (B)(6). THE PRODUCT EXPIRED JANUARY 2014. THE FACILITY USES A ¿GRAFT TRACKER SYSTEM¿ AND WAS TAKEN OUT OF THEIR SYSTEM, BUT SOMEHOW MADE ITS WAY BACK TO THEIR INVENTORY. THE DOCTOR WAS TOLD AT THE END OF THE CASE THAT HE HAD USED THE EXPIRED PRODUCT AND HE LET THE PATIENT KNOW AND THERE HAS BEEN NO PROBLEMS WITH THE PATIENT. NO PATIENT OR USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339096 ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES FILLER, BONE VOID, CALCIUM COMPOUND MQV BAXTER APATECH LTD ELS80F1535DP

    Patients

    Seq Age Sex Outcome Treatment
    1