BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 20794219 · Received November 27, 2024

    Report

    Report Number
    1030489-2024-01586
    Event Type
    Injury
    Date Received
    November 27, 2024
    Date of Event
    February 26, 2013
    Report Date
    November 27, 2024
    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
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: THE COUNTRY OF THE EVENT IS BRAZIL. A2: AGE - MEAN AGE OF 15 PATIENTS WAS 45.7 +/- 11.4 YEARS. A3A: SEX - 8 FEMALE AND 7 MALE PATIENTS OUT OF TOTAL 15 PATIENTS. CITATION: LUIZ PIMENTA, LUIS MARCHI, LEONARDO OLIVEIRA, ETEVALDO COUTINHO AND RODRIGO AMARAL. J NEUROL SURG A. 2013. 74:343¿350. A PROSPECTIVE, RANDOMIZED, CONTROLLED TRIAL COMPARING RADIOGRAPHIC AND CLINICAL OUTCOMES BETWEEN STAND-ALONE LATERAL INTERBODY LUMBAR FUSION WITH EITHER SILICATE CALCIUM PHOSPHATE OR RH-BMP2. DX.DOI.ORG/ 10.1055/S-0032-1333420. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    CITATION: LUIZ PIMENTA, LUIS MARCHI, LEONARDO OLIVEIRA, ETEVALDO COUTINHO AND RODRIGO AMARAL. J NEUROL SURG A. 2013. 74:343¿350. A PROSPECTIVE, RANDOMIZED, CONTROLLED TRIAL COMPARING RADIOGRAPHIC AND CLINICAL OUTCOMES BETWEEN STAND-ALONE LATERAL INTERBODY LUMBAR FUSION WITH EITHER SILICATE CALCIUM PHOSPHATE OR RH-BMP2. DX.DOI.ORG/ 10.1055/S-0032-1333420. EVENT SUMMARY: THE OBJECT OF THIS STUDY WAS TO EXAMINE OUTCOMES OF A 3- YEAR, PROSPECTIVE, RANDOMIZED STUDY COMPARING RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN 2 (RH-BMP2) AND SILICATE CALCIUM PHOSPHATE (SICAP) AS BONE GRAFT SUBSTITUTES IN PATIENTS UNDERGOING A SINGLE-LEVEL, STAND-ALONE LUMBAR LATERAL INTERBODY FUSION FOR DEGENERATIVE DISC DISEASE. INCLUSION CRITERIA FOR ENROLLMENT INCLUDED PATIENTS 70 YEARS OF AGE OR YOUNGER (SKELETALLY MATURE) HAVING CHRONIC, SYMPTOMATIC, SINGLE-LEVEL LUMBAR DEGENERATIVE DISEASE AT L4¿L5 (DEGENERATIVE DISC DISEASE [DDD] WITH/WITHOUT GRADE I DEGENERATIVE SPONDYLOLISTHESIS) THAT FAILED TO RESPOND TO A CONSERVATIVE TREATMENT REGIMEN. 15 PATIENTS TREATED WITH RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN 2 IN COLLAGEN SPONGE (RH-BMP2, INFUSE) AS BONE GRAFT SUBSTITUTES. 53.3% (8) AMONG 15 PATIENTS ARE FEMALE WITH AVERAGE AGE OF 45.7+/- 11.4 YEARS. SUBSIDENCE WAS CONSIDERED WHEN 50% OR MORE OF DISC SPACE LOSS WAS OBSERVED.  ABSENCE OF BRIDGING BONE AT THE INTERVERTEBRAL SPACE WAS DEFINED AS NO FUSION.  REPORTED EVENTS: NO INTRAOPERATIVE COMPLICATIONS WERE OBSERVED. AT THE FINAL EVALUATION, CT SHOWED THAT ALL PATIENTS ACHIEVED SOLID FUSION AT THE INDEX LEVEL. 1. ONE CASE OF INSUFFICIENT INDIRECT DECOMPRESSION FOLLOWING STAND-ALONE XLIF WAS OBSERVED, REQUIRING SUBSEQUENT MINI-OPEN DIRECT DECOMPRESSION. 2. INTERBODY GRAFT SUBSIDENCE WAS OBSERVED IN TWO CASES IN THE RH-BMP2 GROUP, ONE OF WHICH REQUIRED A DIRECT POSTERIOR DECOMPRESSION. 3. IN ONE CASE (1/15; 7%), RHBMP-2 LIKELY CONTRIBUTED TO EXCESSIVE BONE FORMATION IN THE NEURAL FORAMEN AFTER SUBSIDENCE OF THE INTERBODY CAGE. A SUBSEQUENT POSTERIOR DECOMPRESSION WAS REQUIRED TO REMOVE THE EXCESSIVE BONE AND DECOMPRESS THE FORAMEN. 4.  SURGERIES FOR ADJACENT SEGMENT DISEASE OCCURRED IN THREE CASES (20%) IN THE RHBMP-2 GROUP. 5. TRANSIENT HIP FLEXION WEAKNESS (MAXIMUM 6 WEEK LONG) ON THE SIDE IPSILATERAL TO THE APPROACH WAS OBSERVED IN TWO CASES DUE TO ILIOPSOAS MUSCLE IRRITATION DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849577 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 45 YR Female Required Intervention| O