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

Catalog Number 7510600

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

Patient Problems Ossification (1428); Inflammation (1932); Neuropathy (1983); Pain (1994); Stenosis (2263); Numbness (2415); Disc Impingement (2655)

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2012, the patient underwent a posterior approach spine fusion surgery on the lumbar region from l1-s1 where rhbmp-2/acs was implanted.Post-operatively, the patient initially had relief, followed by lower back pain.On (b)(6) 2012, a ct scan revealed disc osteophyte and facet arthropathy causing moderate foraminal stenosis on the right at the level of the surgical site.On (b)(6) 2014, a ct scan noted a 9x31x2.5 mm fluid collection dorsal to thecal sac at the implant site.There was also a 6x29mm fluid collection and a broad disc protrusion that contribute to bilateral foraminal narrowing at the levels of surgery.The patient continues to experience consistent lower back pain and numbness, and left lumbar radiculitis that radiates down his lower extremities.The patient is unable to practice and enjoy the activities of daily life that he enjoyed post-operatively.

Manufacturer Narrative

(b)(6).(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.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.

Manufacturer Narrative

(b)(6).

Event Description

It was reported that on (b)(6) 2012 the patient underwent 1) gill procedure at l5.2) laminectomy, bilateral at l4 3) foraminotomies, bilateral, at: l3-4, l4-5 and l5-s1.4) internal stabilization from l1 through s1, bilateral, using a pedicle screw and rod system.5) posterior and lateral mass fusion from l1 through s1, bilateral, using autogenous bone plus autologous bone plus bone morphogenic protein.6) preparation of bone graft.7) intraoperative fluoroscopy.Perop notes: the greatest instability was at l5-s1 as anticipated.The spinous processes were resected from l1 through s1.This plus all additional bone removed was debrided of attached soft tissue, mixed with 90ml of cancellous bone chips hydrated in antibiotic containing saline solution, and morcellated in a bone mill for later use of graft.After this gill procedure was carried out.After foraminotomies were carried out at l3-4, l4-5, l5-s1, a bilateral laminectomy was also carried out at l4 including medial facets on each side.Following the completion of the decompressive portion of the procedure, the thecal sac and exiting roots were free of the extrinsic distortion.The remaining bone posteriorly was decorticated with a drill.The facet joint cartilage was resected with a drill and rongeurs.Holes were made through the pedicles bilaterally with a drill at l1, l2, l3, l4, l5 and s1.The holes were tapped and then variable angle head pedicle screws were placed at each site under fluoroscopic control.A single crosslink completed the construct.This provided the rigid stability across the operated levels and returned to the spine to normal alignment.The bone graft prepared, as previously described, was placed bilaterally over the decorticated bone from l1 through s1 and packed within the remaining facet joint spaces.Two large rhbmp-2/acs packages were reconstituted according to the supplier's instructions and allowed to assimilate for more than 45mins.The rhbmp-2/acs was carefully placed over the bone graft bilaterally from l1 through s1, taking care to make sure none entered the spinal canal at any time.

• 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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4513196
• MDR Text Key: 5440978
• Report Number: 1030489-2015-00290
• 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,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: 7510600
• Device Lot Number: M111108AAF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/27/2012
• 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