MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Muscle Spasm(s) (1966); Neuropathy (1983); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Notes: 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.Multiple products were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.

Event Description

It was reported that on: on (b)(6) 2008: the patient was pre-operatively diagnosed with severe axial low back pain associated with bilateral sciatica and underwent the following procedures: l4, l5 procedure with decompression of neural elements.L4-l5, l5-s1 posterolateral fusion.L4-l5, l5-s1 interbody fusion.Cage application with bone morphogenic protein, l4-l5, l5-s1.Segmental pedicle screw instrumentation utilizing pedicle screw system, l4-l5, l5-s1.Local autograft morcellized.As per op-notes, ¿surgeons tamped a cage after cleaning off the endplates, a 26 mm length x 10 mm height, packed with bone morphogenic protein.Then they took bone morphogenic protein pallets wrapped around graft and jammed it in between and then put another cage on the opposite side.They did a similar process at l4-l5 except using 22 mm length x 12 mm height cages.One could palpate the sides quite easily and 6.5 x 40 was placed at l4, l5 and s1.They then decorticated the transverse process of the lateral facets, achieved hemostasis took the remaining graft and bone morphogenic protein, the local bone that had been harvested and run through the bone mill and we used 10- cc total of demineralized bone matrix and just gently put this out in the lateral gutters.¿ the patient tolerated the procedure well and no complications were reported.Allegedly, the patient's "post-operative period was marked by a period of improvement, followed by increasingly severe low back pain and spasms, pain radiating to his lower extremities, and numbness and weakness in his lower extremities." on (b)(6) 2008: the patient underwent ct of lumbar spine without contrast status post lumbar fusion.Impression: interval laminectomy l4-l5, l5-s1 with interbody disc separator material placed and posterolateral fusion accomplished with bilateral pedicle screws from l4 through s1 and posterolateral rods.Alignment is attained on the sagittal view.On (b)(6) 2008: the patient underwent mri of the cervical spine due to neck pain.Impression: degenerative disc change at multiple levels.No significant compromising lesions are appreciated.On (b)(6) 2008: the patient underwent ct of the lumbar spine due to intractable back pain.Impression: unremarkable post-operative appearances, status post l4-s1 decompressive laminectomy, fusion and instrumentation.The right l5-s1 neural foramen is mildly narrowed.The patient also underwent mri of lumbar spine due to intractable low back pain.Impression: the spinal canal appears widely patent, status post decompressive laminectomy at l4-s1.Fusion hardware noted.Small postoperative fluid collections in the lateral recesses at l4 and l5-s1, with hematocrit effect.No evidence of abscess formation or arachnoiditis identified.On (b)(6) 2008: the patient underwent bone scan of whole body due to axial low back pain.Conclusion: limited increased isotope accumulation in the lower lumbar spine and the previously operated levels following laminectomy and fusion.On (b)(6) 2008: the patient underwent mri of cervical spine due to upper extremity paresthesias, back spasms.Conclusion: small central disc protrusion at c3-c4.Mild c4-c5 and c5-c6 due to annular bulges.Incidental central disc protrusion at t2-t3 with mild canal stenosis.Post contrast images are unremarkable.On (b)(6) 2008: the patient also underwent ct of lumbar spine post myelogram.Conclusion: osteolysis occurring at the l4-l5 level and to a lesser degree at the l5-s1 level, associated with epidural fluid collections and resulting mass effect on the thecal sac and exiting neural elements.On (b)(6) 2008: the patient underwent a revision surgery due to severe pain.The patient was reported to have continued complaints of low back pain, with pain radiating down both legs.The patient underwent mri which showed migration of the cages probably due to loosening from the osteolysis and they are jutting back into the canal.On (b)(6) 2008: the patient underwent revision surgery due to osteolysis and nonunion, with retropulsed cages in the spinal canal.The dislodged cages were removed and the patient underwent alif.On (b)(6) 2009: the patient underwent ct which showed ectopic bone in the canal, especially around l5/s1.On (b)(6) 2009: the patient underwent ct scan of the lumbosacral spine following intrathecal contrast due to severe low below knee pain and burning of both feet.Conclusion: extensive postoperative changes following instrumented fusion l4-s1.An anterior and posterior fusion was performed at these two levels.No bony alignment.No apparent central canal stenosis.The soft tissues at the operative site are difficult to evaluate.The left l4 pedicle screw traverses the superior vertebral body endplate at this level.Moderate bony encroachment on the neuroforamina at the l5-s1 level.Incidental note is made of moderately advanced facet joint arthritis at multiple levels.These findings are most conspicuous at t12-l1 and l1-l2.On (b)(6) 2009: the patient presented with abdominal pain and shortness of breath.The patient underwent x-ray of chest.Impression: low lung volumes.No acute cardiopulmonary disease.The patient also underwent three views of thoracic spine.Impression: mild convex right scoliosis.Minimal degenerative disc disease within the mid/lower thoracic spine.No acute abnormalities.The patient also underwent three views of the lumbar spine.Impression: posterior spinal instrumentation without evidence for fractures or loosening.No acute abnormalities found.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6013418
• MDR Text Key: 56919963
• Report Number: 1030489-2016-02822
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/19/2016
• Initial Date FDA Received: 10/10/2016
• Supplement Dates Manufacturer Received: 09/19/2016
• Supplement Dates FDA Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Required Intervention