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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Swelling (2091); Inadequate Pain Relief (2388); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 7559817
• Report Number: 1030489-2018-00789
• Device Sequence Number: 1187163
• Product Code: NEK
• UDI-Device Identifier: 00681490843812
• UDI-Public: 00681490843812
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P000058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 06/01/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2010
• Device Catalogue Number: 7510600
• Device Lot Number: M110610AAA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other