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

Catalog Number 7510100

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

Patient Problems Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Burning Sensation (2146); Ambulation Difficulties (2544)

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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on (b)(6) 2015, patient underwent spine fusion surgery, transforaminal lumbar interbody fusion and posterolateral fusion surgery.Reportedly, the patient was implanted with rhbmp-2/acs in this surgery.The rhbmp-2 collagen sponge was placed outside a cage (in the disc space, and posterior elements).Allegedly, patient's post-op period was marked with by a period of improvement, followed by worsening of low back pain and radiculopathy into his left lower extremity.Patient continues to experience chronic and severe pain in his lower left back and burning and stabbing pain radiating down the back of his left leg to his foot.He is unable to stand or sit for extended periods of time and has difficulty turning his body.These serious injuries prevent patient from practicing and enjoying the activities of daily life that he enjoyed pre-operatively, and he has otherwise suffered serious and permanent injuries.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.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 the patient was pre-operatively diagnosed with 1) l3-l4 instability with left l3 pars function 2) intra-and extraforaminal synovial cyst, left l3-l4 and underwent the following procedures: 1) l3, l4 laminectomy, complete left facetectomy l3-4 2) decompression of l3, l4 nerve roots 3) resection of intra- and extraforaminal synovial cysts 4) bilateral pedicle screw fixation l3, l4 5) near complete far lateral discectomy l3-4 6) placement of anterior cage l3-4 7) anterior arthrodesis using bone morphogenic protein 8) posterior and posterolateral arthrodesis using bone autograft bone morphogenic protein.As per op-notes,¿ a control cage was sized to fit the space.The interspace was then filled with locally harvested bone morselized a utograft.Bmp sponge was packed into the disc space as well.A control cage was then filled with bmp sponge and tapped into place using an inserter and mallet and deployed in lordosis.The pedicle screws were then captured using 2 pre-bent 35 mm rods.The entire construct was placed in compression and the cap screws were torqued down to appropriate torque.The remaining posterior and posterolateral elements were then decorticated using a high-speed drill with a cutting bur.The remainder of the morselized autograft and bmp were placed over the posterior and posterolateral elements for posterior and posterolateral arthrodesis.¿ the patient tolerated the procedure well without any intraoperative complications.

• 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: 6208013
• MDR Text Key: 63359432
• Report Number: 1030489-2016-03584
• 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: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: 7510100
• Device Lot Number: M111407AAF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2014
• 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): Other
• Patient Age: 40 YR