BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEOVATION EX INJECT 2CC & 3CC

    MDR report key: 1557142 · Received November 25, 2009

    Report

    Report Number
    3003890476-2009-00003
    Event Type
    Malfunction
    Date Received
    November 25, 2009
    Report Date
    November 25, 2009
    Manufacturer
    SKELETAL KINETICS, LLC
    Product Code
    MQV
    PMA / PMN Number
    K051123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CATALOG # 390-0003. ADDITIONAL LOT #: 08061705. ADD'L EXPIRATION DATE: 06/25/2009. ADDITIONAL DEVICE MANUFACTURE DATE: 07/2008. IN GENERAL, IT IS VERY IMPORTANT TO FLUSH AWAY ANY REMNANTS OF OSTEOVATION FROM THE SOFT TISSUE AFTER THE IMPLANT. THE VOID SHOULD BE FILLED COMPLETELY WITHOUT LEAVING ANY VOID BEHIND, SO NO LOOSE PARTICLES CAN BE FOUND AT THE IMPLANT SITE. THE REP REPORTED THAT THE DOCTOR FILLED THE VOID FIRST WITH PRP (PLATE RICH PLASMA) AND THEN WITH OSTEOVATION; HOWEVER, THE VOID SHOULD BE FILLED WITH OSTEOVATION ONLY AND WE DO NOT KNOW THE PERTINENT INTERACTION OF OSTEOVATION WITH PRP.

    Description of Event or Problem · 1

    THE SURGEON REPORTED SOME DEHISCENCE DEVELOPED SEVERAL WEEKS POST-OP, THE ONLY COMMON VARIABLE WAS OSTEOVATION. THE SURGEON WAS CONCERNED THAT OSTEOVATION WAS CAUSING A REACTION IN SOFT TISSUE AND HE WAS WONDERING IF HE DID NOT FLUSH AND CLEANSE THE SOFT TISSUE OF ANY REMNANTS OF OSTEOVATION AND IF THE MATERIAL LEFT BEHIND IS CAUSING THE TISSUE BREAKDOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOVATION EX INJECT 2CC & 3CC 21 CFR 888.3045 MQV MQV SKELETAL KINETICS, LLC 08040903

    Patients

    Seq Age Sex Outcome Treatment
    1