BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2861564 · Received December 7, 2012

    Report

    Report Number
    1030489-2012-02655
    Event Type
    Injury
    Date Received
    December 7, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Additional Manufacturer Narrative · 1

    DATE OF IMPLANT: (B)(6) 2003 OR (B)(6) 2003. CONFLICTING INFORMATION WAS RECEIVED REGARDING IMPLANT DATE. THE ATTORNEY ALLEGED THE IMPLANT DATE WAS (B)(6) 2003; THE PATIENT REPORTED VIA VOLUNTARY MEDWATCH REPORT THAT THE IMPLANT DATE WAS (B)(6) 2003. NEITHER THE PATIENT'S MEDICAL RECORDS NOR INFORMATION FROM HEALTHCARE PROFESSIONAL HAVE BEEN PROVIDED. WITHOUT ADDITIONAL INFORMATION WE ARE NOT ABLE TO DETERMINE / CONFIRM THE CORRECT IMPLANT DATE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT UNSPECIFIED SURGERY USING RHBMP-2/ACS. REPORTEDLY, THE PATIENT HAS "SEVERE PAIN AND PHYSICAL LIMITATIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R