BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 22517171 · Received July 16, 2025

    Report

    Report Number
    1030489-2025-02443
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Date of Event
    September 2, 2007
    Report Date
    July 16, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 : PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF ACCEPTANCE OF ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED ARTICLE. D4: MODEL, CATALOGUE NO, LOT ARE UNKNOWN. D 6A: IMPLANT DATE IS UNKNOWN. A2: PLEASE NOTE THAT THE AGE IS BASED OFF AVERAGE AGE OF PATIENT INVOLVED IN THIS EVENT. A 3A: PLEASE NOTE THAT THE GENDER IS BASED OFF AS PER THE MAJORITY OF PATIENTS. H6 - 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. ARTICLE REFERENCES - D. KOJO HAMILTON, SEAN M. JONES-QUAIDOO, CHARLES SANSUR, CHRISTOPHER I. SHAFFREY, ROD OSKOUIAN, JOHN A. JANE SR "OUTCOMES OF BONE MORPHOGENETIC PROTEIN-2 IN MATURE ADULTS: POSTEROLATERAL NON¿INSTRUMENT-ASSISTED LUMBAR DECOMPRESSION AND FUSION", SURGICAL NEUROLOGY, 69 (2008) 457¿462, DOI:10.1016/J.SURNEU.2007.09.008. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING OUTCOMES OF BONE MORPHOGENETIC PROTEIN-2 IN MATURE ADULTS: POSTEROLATERAL NON¿INSTRUMENT-ASSISTED LUMBAR DECOMPRESSION AND FUSION THE FOLLOWING MEDTRONIC DEVICES WERE USED: RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 (RH-BMP-2). THIS STUDY WAS A RETROSPECTIVE ANALYSIS THAT COMPREHENSIVELY EXAMINED SPINAL FUSION, FUNCTIONAL OUTCOMES, AND PAIN RELIEF IN AN AGING POPULATION WHERE A BONE MORPHOGENETIC PROTEIN (BMP) WAS UTILIZED. BETWEEN AUGUST 2003 AND JUNE 2004, 55 PATIENTS UNDERWENT SURGICAL TREATMENT FOR LUMBAR DEGENERATIVE DISEASE. THE PROCEDURES INCLUDED MULTILEVEL LUMBAR LAMINECTOMIES WITH MEDIAL FACETECTOMIES AND POSTEROLATERAL FUSION, UTILIZING RHBMP-2 AS THE ACTIVE AGENT. FORTY-SEVEN PATIENTS WERE AVAILABLE FOR FOLLOW-UP AND PARTICIPATED IN THE STUDY. PREOPERATIVE SYMPTOMS WERE DEBILITATING BACK PAIN, RADICULAR SYMPTOMS AND NEUROGENIC CLAUDICATION. ONE PATIENT PASSED AWAY FROM UNRELATED CAUSES DURING THE FOLLOW-UP PERIOD. OF THE 47 PATIENTS, 38 (80%) ACHIEVED SIGNIFICANT FUSION, WHILE 2 EXPERIENCED MINIMAL DISABILITY, BUT HAD NO FUSION. SEVEN PATIENTS REPORTED LOWER THAN MODERATE DISABILITY BY THE STUDY'S CONCLUSION. COMPLICATIONS AROSE IN 5 PATIENTS (9%), NECESSITATING ADDITIONAL SURGERIES: 2 CASES OF EPIDURAL HEMATOMAS, 1 CASE OF THECAL SAC COMPRESSION DUE TO BMP-SOAKED COLLAGEN SPONGE MIGRATION, 1 CASE OF DEEP WOUND INFECTION, AND 1 CASE OF RADICULAR NERVE IMPINGEMENT. AMONG THESE, ONE PATIENT WITH AN EPIDURAL HEMATOMA AND ANOTHER WITH A DEEP WOUND INFECTION REQUIRING WASHOUT AND DEBRIDEMENT WERE PART OF THE GROUP THAT DEVELOPED PSEUDOARTHROSIS. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152116 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P NEK MEDTRONIC SOFAMOR DANEK USA, INC MSB_UNK_BMP2_ACS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female