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 Pain (1994); Tingling (2171); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes.

Event Description

It was reported that on, (b)(6) 2014, patient underwent transforaminal lumbar interbody fusion and posterior fusion from vertebrae l4 to l5.Reportedly, the patient was implanted with rhbmp-2/acs in this surgery.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the disc space, transverse processes and facet joint).Allegedly, patient's post-operative period was marked by a period of improvement, followed by progressively worsening low back and left leg pain, with paresthesias in his thighs.Due to severe pain and symptoms, the patient underwent a revision surgery on (b)(6) 2014.

Manufacturer Narrative

Products from multiple manufacturers 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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on (b)(6) 2014, the patient was pre-operatively diagnosed with l4-l5 left paracentral calcified disk herniation with lateral recess and foraminal stenosis; left l4-l5 radiculopathy and underwent the following procedures: l4-l5 posterior spinal instrumentation with a k2m everest titanium system; l5-l5 posterior spinal fusion with 20 ml of autograft, 4 mg of bone morphogenic protein; l4-l5 bilateral hemilaminectomy and medial facetectomy greater than necessary for a transforaminal lumbar interbody fusion with left l4-l5 calcified diskectomy; l4-l5 transforaminal lumbar interbody fusion,left approach, with placement of an l4-l5 intervertebral cage, ulrich 34 x 16 x 14 height titanium cage and l4-l5 anterior spinal fusion with 4 mg of rhbmp-2 and 5ml of local morselized autograft; intraoperative spinal cord monitoring consisting of somatosensory evoked potentials and electromyography.As per the op notes: ¿i placed 2 mg of rhbmp-2 wrapped around bone matrix into the anterior disk space at l4-l5.This was then supplemented with 5 ml of autograft.This was all tamped down anteriorly.I then placed an ulrich 34 x 16 x 14 mm height titanium cage that was filled with 4 mg of rhbmp-2 and autograft into the disk space.The cage was countersunk below the end plates and placed in the midline.All distraction was then removed.The cage was below the end plates and ventral dura was free.The l4 nerve root was free.We then obtained hemostasis with surgiflo and cottonoids.The placement of the cage was checked on intraoperative x-ray.We then placed intervertebral disk space.We decorticated the posterior elements on the right side including the transverse processes in the l4-l5 facet joint.The posterior lateral fusion was done with 4mg of rh bmp-2 wrapped around bone matrix and supplemented with 15 ml of autograft placed over the transverse process and within the facet joint.¿ patient tolerated the procedure well.

• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6295725
• MDR Text Key: 66316006
• Report Number: 1030489-2017-00195
• 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: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• 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
• Date Manufacturer Received: 09/05/2017
• 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