BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEOVATION IMPACT 5CC

    MDR report key: 1557140 · Received November 25, 2009

    Report

    Report Number
    3003890476-2009-00004
    Event Type
    Malfunction
    Date Received
    November 25, 2009
    Date of Event
    December 2, 2008
    Report Date
    November 25, 2009
    Manufacturer
    SKELETAL KINETICS, LLC
    Product Code
    GXP
    PMA / PMN Number
    K051784
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DOES NOT KNOW THE ROOT CAUSES OF THIS COMPLAINT WITH THE LIMITED INFORMATION PROVIDED; ONE POSSIBILITY COULD BE THAT THE SCALP WAS CLOSED BEFORE THE CEMENT (OSTEOVATION) WAS SET SO THAT THE SKIN WAS EMBEDDED IN THE CEMENT WHILE IT SET; ANOTHER POSSIBILITY COULD BE THE PATCHES FROM THE CEMENT BEING TOO BIG FOR THE SCALP TO COVER. DURING THE FOLLOW-UP VISIT, THE REP SUGGESTED TO THE DOCTOR TO IRRIGATE THE AREA VERY WELL BEFORE CLOSING.

    Description of Event or Problem · 1

    THE DOCTOR PERFORMED CRANIOTOMY, LEFT THE STITCHES IN FOR 11 DAYS, AND A DAY OR SO AFTER REMOVING THEM, THE INCISION SITE SPLIT. IT WAS ALSO REPORTED THAT OSTEOVATION DID NOT MIX AS WELL AS IT USUALLY DOES, BUT IT STILL SEEMED TO WORK WELL. THE DOCTOR THOUGHT IT HAS SOMETHING TO DO WITH OSTEOVATION STICKING TO THE INSIDE OF THE SCALP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOVATION IMPACT 5CC 21 CFR 882.5300 GXP GXP SKELETAL KINETICS, LLC 08080602

    Patients

    Seq Age Sex Outcome Treatment
    1 Other