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 Fall (1848); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Swelling (2091); Inadequate Pain Relief (2388); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented with following pre-op diagnosis: degenerative joint disease, disc space l5-s1 and disc space l4-5.Postlaminectomy instability l5-s1.Internal disc derangement l4-5, l5-s1.Patient underwent following procedures: anterior approach for anterior discectomy, lumbar fusion with cages and bone morphogenic protein, placement of anterior plates.Anterior retroperitoneal approach l4-5, l5-s1.Complete discectomy l4-5, l5-s1.Anterior interbody fusion with bone morphogenic protein and cage l4-5, l5-s1.5.Fixation with plate l4-5, l5-s1.As per operative notes, "a series of sizing devices were used and a 10 degree 14mm, medium size cage was chosen and implanted with bone morphogenic protein in the substance of the cage.The fit seemed quite good.A 43 mm l5-s1 plate was chosen, implanted with 24 mm screws.Sizing devices were again used and a 16 mm,5 degree, medium size cage was implanted with bone morphogenic protein within the substance of the cage.The fit seemed quite good.A 43 mm l4-5 plate was; chosen and implanted with 26 mm screws." non intra-operative complications were reported.On (b)(6) 2007 the patient got discharged from the facility.It was reported that, post-op, the patient complained of increasing low back pain and associated radiculopathy in his lower extremities.The patient continued to experience extreme back pain, with pain radiating down to his hips and legs, muscle spasms in his left leg, numbness in his left toes, and occasional swelling in his back.The patient experienced difficulty in walking and falls constantly due to paralyzing pain.These injuries prevent patient from practicing and enjoying the activities of daily life.

• 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: 7559817
• MDR Text Key: 109741201
• Report Number: 1030489-2018-00789
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843812
• UDI-Public: 00681490843812
• 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
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2010
• Device Catalogue Number: 7510600
• Device Lot Number: M110610AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2007
• 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