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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Dysphagia/ Odynophagia (1815); Inflammation (1932); Nausea (1970); Pain (1994); Ambulation Difficulties (2544)

Event Date 04/18/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent anterior cervical discectomy and fusion (acdf) due to herniated disc at c5-c6.Post -op, the patient had suffered from swallowing problems and severe pain.The patient had acdf c5-c6 surgery and his surgeon used rhbmp-2/acs.The patient had the surgical report started having swallowing problems and severe pain right after which prompted the patient to see the surgeon.The surgeon started imagining etc and concluded nothing was wrong.The patient kept returning with pain until it got so bad; the patient could not walk, swallow food, go to the bathroom and lastly ended up in the 'er' this past because the bone graft and cage were grown into patient's spinal canal impinging on patient's spinal cord.The surgeon left the patient waiting 9 days in agonizing pain never bothered to even come and check on while the patient was in the hospital.He blamed it on the hardware, said maybe the patient was allergic and said he saw a lot of inflammation but the patient's ct report said the patient was in so much pain and nauseated everyday.The patient was disabled because of that.

• 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: 8815246
• MDR Text Key: 151849708
• Report Number: 1030489-2019-00799
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2019
• 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