BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2025388 · Received March 21, 2011

    Report

    Report Number
    1030489-2011-00318
    Event Type
    Injury
    Date Received
    March 21, 2011
    Report Date
    February 21, 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

    (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 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. 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

    (RESULTS) THE AVERAGE AGE OF THE STUDY PATIENTS WAS (B)(6) YEARS. THE STUDY CONSISTED OF 468 MALES AND 690 FEMALES. BONE VOID FILLER (DETAILS NOT PROVIDED) POSTERIOR INSTRUMENTATION (DETAILS NOT PROVIDED) REFER TO MANUFACTURER REPORTS 1030489-2001-00323, 1030489-2011-00319, 1030489-2011-00320, 1030489-2011-00321, 1030489-2011-00322, 10 30489-2011-00324 FOR MORE DETAILS REGARDING SURGICAL COMPLICATIONS.

    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. ONE HUNDRED SEVENTEEN PATIENTS REQUIRED REPEAT SURGERY DUE TO SURGICAL COMPLICATIONS. MORE THAN ONE COMPLICATION OCCURRED IN SOME OF THE 117 PATIENTS. TWO PATIENTS UNDERWENT HARDWARE REMOVAL AFTER ONE AND TWO YEARS WITH THE CORRESPONDING FUSION BEING DESCRIBED AS VERY SOLID.

    Description of Event or Problem · 1

    POST OPERATIVE COMPLICATIONS WERE REPORTED IN A RETROSPECTIVE STUDY PRESENTATION OF PATIENTS WHO UNDERWENT INSTRUMENTED LUMBAR POSTE ROLATERAL FUSION WITH RHBMP-2 FOR DEGENERATIVE SPINE CONDITIONS BETWEEN 2002 AND 2009. PATIENT RISK FACTORS INCLUDED DIABETES, CARDIOVASCULAR DISEASE, RESPIRATORY DISEASE, TOBACCO USE, ANTI-INFLAMMATORY DRUG USE, STEROID MEDICATION, ALLERGIES, NON-UNION, INFECTION, INSTRUMENTATION AND LEVELS FUSED. ONE HUNDRED SEVENTEEN PATIENTS REQUIRED REPEAT SURGERY. 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 Required Intervention