BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2071042 · Received April 27, 2011

    Report

    Report Number
    1030489-2011-00459
    Event Type
    Death
    Date Received
    April 27, 2011
    Report Date
    March 29, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVERAGE AGE OF THE STUDY PATIENTS WAS (B)(6) YEARS. THE AGE OF THIS PATIENT IS UNKNOWN. THE STUDY CONSISTED OF 468 MALES AND 690 FEMALES. THE GENDER OF THIS PATIENT IS UNKNOWN. THE DATE OF DEATH IS AN ESTIMATED DATE; THE ACTUAL DATE OF DEATH IS UNKNOWN. THE DATE PROVIDED WAS FOR EMDR TRANSMISSION PURPOSES. BONE VOID FILLER (DETAILS NOT PROVIDED) POSTERIOR INSTRUMENTATION (DETAILS NOT PROVIDED). (B)(4). A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. ALTHOUGH IT IS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    POST OPERATIVE COMPLICATIONS WERE REPORTED IN A RETROSPECTIVE STUDY OF PATIENTS WHO UNDERWENT INSTRUMENTED LUMBAR POSTEROLATERAL FUSION WITH RHBMP-2 AT A SINGLE PRACTICE BY FIVE ORTHOPEDIC SURGEONS BETWEEN (B)(6) 2002 AND (B)(6) 2009. PERSISTENT SYMPTOMS REFRACTORY TO NON-OPERATIVE TREATMENT INCLUDED NONSTEROIDALS, PHYSICAL THERAPY AND/OR SPINAL INJECTIONS EXISTED. THE MEAN TOTAL BMP-2 DOSE WAS 12.5 MG PER PATIENT (RANGE 4.2-36.0). PATIENT FOLLOW-UP OCCURRED AT TWO WEEKS, SIX WEEKS, TWELVE WEEKS, SIX MONTHS, ONE YEAR AND LATER IF REQUIRED. IT WAS REPORTED THAT THE PATIENT DIED DURING HOSPITALIZATION AS A RESULT OF PULMONARY EMBOLISM. NO FURTHER DETAILS WERE PROVIDED.

    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 NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Death