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

Catalog Number	7510200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
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.Products from multiple manufacturers were also implanted.Although it is unknown if the reported device contributed to the reported event, we are filing this mdr for notification purposes.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported per patient medical records that on: (b)(6) 2007: the patient presented with the following pre-operative diagnosis: cervical degeneration.The patient underwent the following procedures: c6-c7 diskectomy.C6-c7 interbody fusion.Interbody implant.Anterior plating.As per operative notes, ¿a 7 mm lordotic spacer was selected.Bmp-2 measuring one-half of a strip was placed.The plate was placed with 13 mm screws.Crosstable lateral radiograph was taken to confirm proper graft and hardware placement.¿ on (b)(6) 2007: the patient was discharged.On (b)(6) 2019: the patient presented with the following pre-operative diagnosis: c5-c6 adjacent segmental disease.The patient underwent the following procedure: anterior cervical discectomy and fusion c5-c6.Implants, manufactured by other manufacturers, were used in this surgery.As per operative notes, ¿we placed a mosquito clamp onto the disc space and verified the position with lateral fluoroscopy confirming the operative level c5-c6.A large osteophyte which i removed and sent to pathology.Explored the fusion beneath that i didn¿t see any plate.It appears to have dissolved or converted to bone and was a solid fusion from c6 through c7.A knife was used to cut the annulus anteriorly.A curette, pituitary and kerrison were used to remove all the disc material.We found disc osteophyte complex right 56 neuroform.This was removed for a nice decompression, there was nothing affecting the nerve and the neural foramen was open.We then decorticated the bony end plates and had nice punctate bleeding.We selected an approximately sized structural allograft which we coated in morselized allograft.We gently malleted this into position a selected an anterior cervical plate , secured it with screws and locked them into position.Patient complained of severe pain with unspecified "problems" and "issues" since the surgery.No other details were provided by the patient.

• 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: 8827807
• Report Number: 1030489-2019-00816
• Device Sequence Number: 11362716
• Product Code: NEK
• UDI-Device Identifier: 00681490843782
• UDI-Public: 00681490843782
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2019

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: 10/01/2009
• Device Catalogue Number: 7510200
• Device Lot Number: M110602AAH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/25/2019
• 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