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

Catalog Number 7510400

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Neuropathy (1983); Burning Sensation (2146); Cramp(s) (2193)

Event Type  Injury  

Manufacturer Narrative

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 (b)(6) 2015, the patient underwent transforaminal lumbar fusion surgery on the lumbar region of her spine from vertebrae l4to l5.Reportedly, patient was implanted with rhbmp-2/acs in this surgery.The rhbmp-2 collagen sponge was placed out side a cage, i.E., in the disc space.Allegedly, the patient's post-operative period was marked by increasing low back pain, burning pain in her right leg, and severe cramping in both legs.The patient underwent revision surgery on (b)(6) 2015, due to severe pain and symptoms.Reportedly, the patient continued to experience "constant and extreme lower back and leg pain.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

It was reported that on: (b)(6) 2015: the patient was preoperatively diagnosed with l4-5 spondylolisthesis lumbar stenosis with radiculopathy and underwent the following procedures: bilateral l4-l5 transforaminal lumbar interbody fusion posterior spinal instrumentation l4-l5 with 4.75mm screws in a cortical screw trajectory placement of interbody cage l4-l5, 8mm local autograft medium rhbmp-2/acs use of intraoperative o-arm navigation for placement of the cortical screws.As per the op notes: ¿due to the previous laminectomy at l4-5 i encounter epidural fibrosis that made the exposure of the disc space and tlif at least 25% more difficult.I gently retracted the traversing nerve root.We trialed for the appropriate size interbody device.This was packed with a medium rhbmp-2/acs, inserted and rotated into place.Local bone graft was then packed behind the cage and rhbmp-2/acs on both sides.¿the patient tolerated the procedure well without any intraoperative complications.Post-operatively, the patient was diagnosed with l4-5 isthmic spondylolisthesis.On (b)(6) 2015: the patient was discharged from the facility.On (b)(6) 2015: the patient was preoperatively diagnosed with persistent right lower extremity radiculopathy due to extruded bone graft from the right l4-l5 foramen and underwent the following procedures: removal and re-instrumentation right l4-l5.Repeat decompression, right l4-l5 foramen with removal of extruded bone fragments.The patient underwent ct scan prior to surgery which showed what appeared to be extruded bone graft in the right l4-l5 foramen.On (b)(6) 2015: the patient was discharged from the facility.

• 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: 6013403
• MDR Text Key: 56917668
• Report Number: 1030489-2016-02819
• 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,Followup
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2016
• Device Catalogue Number: 7510400
• Device Lot Number: M111502AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2017
• 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