MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P

Model Number MSB_UNK_BMP2_ACS

Device Problem Off-Label Use (1494)

Patient Problem Pain (1994)

Event Type  malfunction  

Event Description

Summary: this report presented femoral ring spacer filled with an rhbmp-2-soaked sponge was retrieved from a woman who had undergone a combined anterior and posterior spinal reconstruction but had early dislodgment of the interbody graft.Retrieval and analysis of an rhbmp-2-soaked collagen sponge in contact with allograft bone was conducted.Reported event: an off-label use of rhbmp-2 with structural allograft bone in anterior lumbar interbody arthrodesis has been reported.A sixty-one-year-old woman presented to the institution chiefly because of incapacitating back pain and worsening bilateral thigh and calf pain while walking.Three years earlier, she had undergone lumbar laminectomy without arthrodesis as treatment for similar symptoms.A diagnosis of neurogenic claudication, post laminectomy instability, and progressive scoliosis was made on the basis of the clinical and radiographic findings.The patient underwent a combined anterior and posterior reconstruction of the thoracolumbar spine and a revision lumbar decompression.The first stage of the procedure included an anterior interbody release and arthrodesis from l2 to l5.A thorough discectomy was done at each of these levels, with the end plates of the vertebral bodies prepared to bleeding bone.Infuse bone graft (medtronic) was reconstituted according to the manufacturer¿s instructions and placed onto a collagen sponge sheet.The sheet was then divided into three sections and packed into three femoral ring allografts.The allograft-rhbmp-2 spacers were inserted into the disc spaces of l2-l3, l3-l4, and l4-l5 to promote arthrodesis as well as to support the anterior column.The second stage of the procedure included an l2 to l5 revision laminectomy and foraminotomies as well as posterior spinal arthrodesis with instrumentation from t6 to l5 with iliac crest bone graft.The patient recovered uneventfully postoperatively and was discharged from the hospital in stable condition.Use of infuse was at 3 levels, 4mg/level.Three months after the procedure, the patient fell and presented with new-onset low-back pain.Lumbar radiographs revealed that the anterior half of the femoral ring allograft was protruding from the l4-l5 interspace.At six months, the follow-up radiographs revealed that the graft had completely extruded from the l4-l5 disc space.So the decision was made to perform a revision surgical reconstruction involving removal of the posterior instrumentation, retrieval of the extruded femoral ring allograft, revision of the anterior lumbar interbody arthrodesis with extension of the anterior arthrodesis to the l5-s1 level, and revision of the posterior instrumentation with extension of the arthrodesis to the sacrum and pelvis.On removal of implant 6 months post op due to extrusion of femoral ring from the disc space, the rhbmp-2/acs implant was easily removed from the ring.During that operation, the implant was found to have migrated anterior to the vertebral column without any evidence of incorporation into the vertebral bodies.The intervertebral space had collapsed, no woven bone was noted within the intervertebral space, and there was no evidence of ossification of the adjacent tissue.Gross analysis of the retrieved specimen showed that the absorbable collagen sponge, which had been packed into the center portion of the femoral ring, could be separated easily from the allograft.The decalcified sections showed mostly woven bone, some lamellar bone, rare cartilaginous tissue, and no evidence of a residual collagen sponge.There were rare neutrophils and macrophages at the margins of the specimen, which was consistent with a mild inflammatory reaction to the extruded allograft-collagen sponge complex.A very small number of lymphocytes were present within the substance of the new bone, but no neutrophils or macrophages were observed.Numerous lacunae with osteocytes were present and cement lines were visible in areas of lamellar bone.The cartilaginous areas were rare, but present, suggesting that bone formation may have occurred through a chondrogenic stage.Abundant viable cells were seen within the cartilaginous tissue.Von kossa staining of the undecalcified specimen demonstrated abundant mineralized tissue.The specimen (the former rhbmp-2/acs implant) was firm but compressible, similar to the consistency of cancellous bone.

Manufacturer Narrative

B3: date of event unknown.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.Joon y.Lee, steven zeiller, lysandra voltaggio, moe r.Lim, alan s.Hilibrand, alexander r.Vaccaro, d.Greg anderson, todd j.Albert."histological analysis of a displaced femoral ring allograft spacer filled with a recombinant human bone morphogenetic protein-2-soaked collagen sponge." journal of bone and joint surgery.Volume 87-a, number 10, doi:10.2106/jbjs.D.03034.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.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 18966219
• MDR Text Key: 338992296
• Report Number: 1030489-2024-00203
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_BMP2_ACS
• Device Catalogue Number: MSB_UNK_BMP2_ACS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female