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 Pain (1994); Swelling (2091); 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.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) 2013, patient was admitted to the facility where the surgeon performed spine fusion surgery using rhbmp2 on the lumbar region of his spine from vertebrae l2 to l5.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.The rhbmp-2 collagen sponge was placed outside a cage (i.E., over the posterior elements).Post-op, " patient continues to experience constant mid and upper back pain, with pain radiating throughout his entire back and down his legs, numbness throughout his body, muscle spasms and swelling on his right side, and muscle spasms in his right arm and hand.Patient experiences difficulty sitting, standing and walking, and must use a walker to assist in ambulation.".

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

The patient was pre-operatively diagnosed with 1) lumbar spinal stenosis l2-l3, l3-l4 and l3-l5 2) lumbar degenerative scoliosis and spinal stenosis, l2 to l5 and underwent the following procedures: 1) bilateral l2-l3, l3-l4, l4-l5 laminotomies, foraminotomies, and medial facetectomies.2) posterior spinal fusion, l2 to l5.3) pedicle screw instrumentation, l2 to l5.4) right iliac crest bone graft.As per op-notes,¿ rods were cut and bent to the appropriate amount of lordosis, placed in polyaxial heads of the pedicle screws secured using cap screws.We then applied slight compression on the convexity of the curve on the left.The heads of the cap screws were then sheared off.This completed the segmental instrumentation.We harvested right iliac crest bone graft by tunneling subcutaneously over the lumbodorsal fascia out to the right iliac crest where we harvested cancellous graft between the inner and outer tables.The graft site was copiously irrigated, filled with floseal and gelfoam and closed with a #1 vicryl suture.We then turned our attention back to the main spinal wound.We performed a posterolateral arthrodesis.We decorticated transverse processes from l2 to l5.We laid strips of rhbmp2/ acs over decorticated posterior elements followed by right iliac crest bone graft followed by local bone obtained from the laminectomy.This completed posterolateral arthrodesis from l2 to l5.

• 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: 6019981
• MDR Text Key: 57052660
• Report Number: 1030489-2016-02853
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510800
• Device Lot Number: M111113AAI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/19/2016
• Initial Date FDA Received: 10/12/2016
• Supplement Dates Manufacturer Received: 09/19/2016; 02/26/2018
• Supplement Dates FDA Received: 09/26/2017; 03/09/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/03/2013
• 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