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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Type  Injury  

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.Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on (b)(6) 2012, patient underwent anterior cervical fusion surgery from vertebrae c4-c6.Reportedly, the patient was implanted with rhbmp-2/acs in this surgery.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.Allegedly, " patient continues to suffer from chronic pain and is prevented from practicing and enjoying the activities of daily life that he enjoyed pre-operatively.".

Manufacturer Narrative

Additional information: products from multiple manufacturers 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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on: (b)(6)2012: the patient was pre-operatively diagnosed with c4-c5 and c5-c6 cervical stenosis secondary to disc osteophyte complexes with right upper extremity radiculopathy and underwent the following procedures: 1) anterior cervical microscopic decompression at c4, c5 and c6 with bilateral foraminotomies at c4-c5 and c5-c6, anterior arthrodesis c4, c5 and c6 with synthes machined allograft spacers, bone morphogenic protein and skyline anterior cervical plate.As per operative notes, "the inferior portion of the c4 body was resected along with the top of the c5.The decompression continued back to the posterior longitudinal ligament which was also partially calcified.There was severe stenosis on the right side and it was not possible to pass a probe on the right side.The left side was moderately stenotic.The wide foraminotomies were performed bilaterally.The spinal cord was decompressed as well.9-mm machined allograft spacers were selected and a small hole was drilled in the spacers and a small piece of bmp (bone morphogenic protein) was placed within the confines of each spacer.¿ the patient tolerated the procedure well without any intraoperative complications.The patient was discharged from the hospital on the same day.

• 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: 6208021
• MDR Text Key: 63359221
• Report Number: 1030489-2016-03591
• 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: 01/25/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: 12/05/2016; 01/08/2018
• Supplement Dates FDA Received: 09/28/2017; 01/25/2018
• Was Device Evaluated by Manufacturer?: No
• 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