BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 22936031 · Received September 2, 2025

    Report

    Report Number
    3003120897-2025-00163
    Event Type
    Injury
    Date Received
    September 2, 2025
    Date of Event
    December 30, 2009
    Report Date
    September 2, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NEK
    PMA / PMN Number
    P000054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: KWANG-BOK LEE, CYRUS E. TAGHAVI, MARGARET S. HSU, KYUNG-JIN SONG, JEONG HYUN YOO, GUN KEOROCHANA, STEPHANIE S. NGO AND JEFFREY C. WANG. THE EFFICACY OF RHBMP-2 VERSUS AUTOGRAFT FOR POSTEROLATERAL LUMBAR SPINE FUSION IN ELDERLY PATIENTS. EUR SPINE J. 2010. 19:924¿930. 10.1007/S00586-009-1248-6. 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

    CITATION: KWANG-BOK LEE, CYRUS E. TAGHAVI, MARGARET S. HSU, KYUNG-JIN SONG, JEONG HYUN YOO, GUN KEOROCHANA, STEPHANIE S. NGO AND JEFFREY C. WANG. THE EFFICACY OF RHBMP-2 VERSUS AUTOGRAFT FOR POSTEROLATERAL LUMBAR SPINE FUSION IN ELDERLY PATIENTS. EUR SPINE J. 2010. 19:924¿930. 10.1007/S00586-009-1248-6. EVENT SUMMARY: THE PURPOSE OF THIS RETROSPECTIVE STUDY IS TO EVALUATE THE EFFICACY OF RHBMP-2 WITH ALLOGRAFT VERSUS AUTOGRAFT FOR PO STEROLATERAL LUMBAR FUSION IN PATIENTS 65 YEARS AND OLDER. ONE HUNDRED TWENTY-SEVEN PATIENTS WERE DIVIDED INTO THREE GROUPS BASED ON FUSION MATERIAL AND AGE. SUBJECTS IN GROUP A (N = 34) CONSISTED OF PATIENTS 65 YEARS AND OLDER WHO RECEIVED RHBMP-2 AND ALLOGRAFT. GROUP B (N = 52) WAS COMPOSED OF PATIENTS UNDER 65 YEARS OF AGE WITH RHBMP-2 AND ALLOGRAFT. SUBJECTS IN GROUP C (N = 41) WERE 65 YEARS AND OLDER WITH AUTOGRAFT USE. PATIENTS WERE INCLUDED IF THEY UNDERWENT INSTRUMENTED PLF FOR THE TREATMENT OF DEGENERATIVE LUMBAR SPINE DISEASES BETWEEN 2002 AND 2006, IF THEIR PROCEDURE UTILIZED RHBMP-2 WITH ALLOGRAFT (RHBMP-2 USE GROUP) OR AUTOGRAFT ONLY (AUTOGRAFT USE GROUP), AND IF THERE WAS AT LEAST 2 YEARS OF FOLLOW-UP. 127 PATIENTS WERE ENROLLED IN THIS STUDY AND WERE DIVIDED INTO THREE GROUPS BASED ON THEIR AGE AT THE TIME OF SURGERY AND GRAFT MATERIAL. GROUP A (N = 34) WAS COMPOSED OF PATIENTS 65 YEARS AND OLDER WHO HAD RECEIVED RHBMP-2 WITH ALLOGRAFT [MEAN AGE 74.1 ± 5.8 YEARS (MIN 65, MAX 91); 18 MALE AND 16 FEMALE; 5 SMOKERS; 14 WITH OST EOPOROSIS; 18 WITH MEDICAL COMORBIDITIES; 12 REVISION SURGERIES; 17 MULTILEVEL FUSIONS]. GROUP B (N = 52) WAS DEFINED AS PATIENTS LESS THAN 65 YEARS WITH RHBMP-2 AND ALLOGRAFT USE [MEAN AGE 49.9 ± 11.2 YEARS (MIN 17, MAX 64); 20 MALE AND 32 FEMALE; 14 SMOKERS; 6 WITH OSTEOPOROSIS; 9 WITH MEDICAL COMORBIDITIES; 26 REVISION SURGERIES; 13 MULTILEVEL FUSIONS). FUSION WAS DEFINED AS THE PRESENCE OF BILATERAL BRIDGING TRABECULAR BONE ON PLAN RADIOGRAPHS WITH LESS THAN 3 DEGREES OF TRANSLATION AND LESS THAN 5 DEGREES OF ANGULATION ON FLEXION/EXTENSION VIEWS. REPORTED EVENTS: 1. THE FUSION RATE WAS 82.4% (28/34) IN GROUP A AND 94.2% (49/52) IN GROUP B (P = 0.146). THE REVISION SURGERY RATE WAS 16.7% (1/6) IN GROUP A AND 0% (0/3) IN GROUP B. 2. TWELVE (35.3%) PERIOPERATIVE COMPLICATIONS OCCURRED IN GROUP A (1 DURAL TEAR, 2 CARDIAC PROBLEMS, 2 GASTROINTESTINAL PROBLEMS, 1 URINARY TRACT INFECTION, 1 NEUROLOGICAL DEFICIT, 3 DEEP VEIN THROMBOSES AND 1 WOUND INFECTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248183 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 NA Female Required Intervention