BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILLER, BONE VOID, CALCIUM COMPOUND

    MDR report key: 2256966 · Received September 14, 2011

    Report

    Report Number
    2530131-2011-00006
    Event Type
    Injury
    Date Received
    September 14, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 19, 2011
    Manufacturer
    ORTHOVITA, INC.
    Product Code
    MQV
    PMA / PMN Number
    K081439
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A BATCH RECORD REVIEW WAS COMPLETED FOR THIS LOT AND NO NON CONFORMANCES WERE NOTED. THE PRODUCT WAS STERILIZED WITH THE CORRECT GAMMA DOSE AND WAS WITHIN SPECIFICATION FOR ENDOTOXIN CONTENT. TWO PRODUCT RETAINS WERE SENT TO A CONTRACT LABORATORY FOR STERILITY EVALUATION. THE RESULTS OF THESE TESTS ARE PENDING. A FOLLOW UP REPORT WILL BE SENT WHEN THESE RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    A PT UNDERWENT A POSTEROLATERAL FUSION WITH THE DEVICE AND DEVELOPED SIGNS OF INFECTION SHORTLY AFTER SURGERY. NO CULTURES WERE PERFORMED BUT IV ANTIBIOTICS WERE ADMINISTERED AND SYMPTOMS SUBSIDED WITHOUT FURTHER SURGICAL INTERVENTION. THIS EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILLER, BONE VOID, CALCIUM COMPOUND VITOSS BA FOAM PACK MQV ORTHOVITA, INC. 2102-1610 B1009021

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention