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	Neuropathy (1983); Pain (1994); Burning Sensation (2146); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was pre-operatively diagnosed with l4-5 and l5-s1 disc herniation with radiculopathy and diskogenic back pain and underwent the following procedures: anterior lumbar interbody fusion at l4-5 and anterior lumbar interbody fusion at l5-s1.Biomechanical device with lt cages paired at l5-s1.Discectomy anteriorly at l4-5 and discectomy anterior at l5-s1.C-arm for localization of device.Allograft nonstructural.As per op-notes,¿ the decompression was performed back to the spinal canal and redundant annulus and clear central disc herniations were removed with pituitary and curette.Again the discectomy was over and above the simple block discectomy.Bmp and allograft were allowed to prepare according to protocol.Deep to the cages, we did place crushed cancellous allograft followed by bmp sponges as well as the cages countersunk to 6 mm.Again attention was turned to the l4-5 level.The disc was removed in to resecting the disc completely, releasing and resecting the annulus and releasing portions of the posterior longitudinal ligament all the way to the posterolateral comers far, above and over the simple block discectomy.The decompression was performed back to the spinal canal.Due to the annular pathology, an obvious disc herniation and more aggressive decompression was done posterolaterally.Bmp and allograft were allowed to cure according to protocol and the cages and bmp with allograft were applied.The patient tolerated the procedure well.¿.Post-op, the patient complained of progressively worsening pain in his low back and radiculopathy into his lower extremities.Patient continues to experience constant low back pain with radiculopathy and burning into his lower extremities.Patient experiences difficulty standing and walking.

• 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: 7364872
• Report Number: 1030489-2018-00441
• Device Sequence Number: 19326871
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 03/23/2018

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: 09/01/2015
• Device Catalogue Number: 7510600
• Device Lot Number: M111202AAC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 03/23/2018
• 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