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

Catalog Number 7510800

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

Patient Problems Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Tingling (2171); Inadequate Pain Relief (2388); Numbness (2415); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4) (persisting back pain).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.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) 2009, the patient underwent transforaminal lumbar interbody fusion and posterior fusion surgery from vertebrae l4 to s1.Reportedly, rhbmp-2/acs was used in this surgery.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.Post-op, the patient suffered from increasing severe low back pain, with pain and radiculopathy in her hips and legs.Severe pain and symptoms ultimately compelled patient to undergo implantation of a neurostimulator.Patient continued to experience chronic lower back, with pain radiating into her hips, and numbness and tingling in both legs.She experienced bowel and bladder issues, difficulty walking, inability to stand for extended periods of time, and must constantly took breaks and sit down.As a result of using a walker in physical therapy, patient developed pain in her shoulders and numbness in the fingers of both hands.Patient also required use of a cane for assistance in ambulation, and a motorized wheel chair for longer distances.These serious injuries prevent patient from practicing and enjoying the activities of daily life.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: 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) 2009, the patient was pre-operatively diagnosed with lumbar stenosis, lumbar spondylolisthesis, and lumbar radiculopathy; and underwent the following procedure: revision and decompression at l5-s1, l4-l5 laminoplasty style laminectomy and l4-l5 and l5-s1 transforaminal lumbar interbody fusion with prosthetic interbody vertebral devices, posterior instrumentation and posterior fusion.As per op-notes,¿ trial interbody spacers were placed and then removed and two globus sustained l interbody implants, 12 mm in width x 8 mm in height x 30 mm in length were each filled with half sponge of rhbmp-2/acs.Another sponge of rhbmp-2/acs was placed in front of the disk space.First interbody implant was placed on the left over to the right and a second interbody implant was placed on the left.Graft was packed posterior to this and distraction was removed from the implants and attention was turned to 4/5.A laminoplasty style laminectomy was performed at l4-l5, decompressing the right-hand side with the left-side approach and a complete facetectomy was performed on the left-hand side.Once the nerves were decompressed annulotomy was performed and the same interbody fusion was performed at l4-l5 as at l5-s1, except for this level the implants were 15 mm in height.Once interbody workup had been completed compression was applied bilaterally at each level and final torquing of the screws was performed.Ap and lateral fluoroscopy conf irmed good placement of the hardware.Fibrin glue was used to seal the posterior aspect of the disk space.A high-speed bur was used to decorticate the lamina and facet joints on the right-sided at l4-l5 and l5-s1 and the sponges of infuse were placed in the facet joints and local bone from the approach was packed on top of the lamina in order to achieve a posterior fusion.Retractors were removed.¿ the patient tolerated the procedure well without an 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: 5768499
• MDR Text Key: 48710902
• Report Number: 1030489-2016-01980
• 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: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2011
• Device Catalogue Number: 7510800
• Device Lot Number: M110808AAH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/22/2009
• 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