BEUDAMED
    FDA Adverse Event Other Summary report: N

    OSTEOVATION INJECT 5CC

    MDR report key: 1553729 · Received November 25, 2009

    Report

    Report Number
    3003890476-2009-00001
    Event Type
    Other
    Date Received
    November 25, 2009
    Date of Event
    May 14, 2007
    Report Date
    November 25, 2009
    Manufacturer
    SKELETAL KINETICS, LLC
    Product Code
    GXP
    PMA / PMN Number
    K051784
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE LOT NUMBER WAS UNK, TWO POSSIBLE LOTS OF CATALOG #390-2005 WERE IDENTIFIED AS POSSIBLY USED FOR THE SURGERY PERFORMED ON (B)(6) 2007. THE BATCH RECORDS OF THESE TWO LOTS MET ALL FUNCTIONAL AND STERILIZATION CRITERIA UPON RELEASE. IN ADDITION TO THE PT HAS PRE-EXISTING CONDITIONS OF DIABETES, CORONARY DISEASE AND HYPERTENSION, GENERAL MEDICAL PRACTICE ALSO INDICATES THAT ORAL CAVITY SURGERIES ARE DIFFICULT AND PRONE TO HAVE INFECTION. INFECTION IS LISTED AS ADVERSE REACTIONS IN THE 510K CLEARANCE SUBMISSION AND THE INSTRUCTIONS OF USE.

    Description of Event or Problem · 1

    ON (B)(6) 2007, OSTEOVATION INJECT 5CC BONE VOID FILLER, LOT NUMBER UNK, WAS USED ON A PT WITH RECURRENT ODONTOGENIC KERATOCYST OF THE LEFT MANDIBLE BODY. THE PT DEVELOPED CHRONIC AND SUBACUTE SOFT TISSUE INFECTION IN AREA OF GRAFTED MATERIAL AND ON (B)(6) 2007 INCISION AND DRAINAGE OF LEFT BUCCAL SPACE INFECTION AND DEBRIDEMENT OF OSTEOVATION GRAFTED MATERIAL WAS PERFORMED, THE STATUS OF THE PT WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOVATION INJECT 5CC 21 CFR 882.5300 GXP GXP SKELETAL KINETICS, LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1