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

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

Patient Problems Nausea (1970); Discomfort (2330)

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.Multiple products 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.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) 2004: the patient was pre-operatively diagnosed with degenerative disc disease l4-l5 and underwent the following procedures: posterior lumbar interbody fusion l4-l5.Insertion of prosthetic intervertebral biomechanical device, peek cage.Posterior nonsegmental instrumentation.Posterior lateral lumbar spine fusion, left side l4-l5.Autograft for spine surgery, same incision.As per op-notes, " the cage was cage that is bullet shaped to allow for opening the disc up with the cage and not taking off as much of the posterior lip margin making this a concave disc shape with a convex implant that made it much less likely to retropulse.Once we clean out the disc space very thoroughly, put some bmp across the midline, bone chips across the midline, bmp in the cage, put the cage in place and then put pedicle screws in, made the holes for pedicle screws to the point of tapping them." on (b)(6) 2006: the patient underwent esophagogastroduodenoscopy due to nausea.Findings: normal esophagus with no endoscopic evidence for esophagitis.Squamocolumnar junction lies at about 37 cm from the incisors.This appears to be the true gastroesophageal junction and there is no evidence for cle or for stenosis.Stomach was normal with no evidence for any erosive, infiltrative or retentive process.Normal duodenum through the second portion.The patient also underwent colonoscopy due to abdominal discomfort and a family history of colon polyps.Findings: complete colonoscopy to the cecum/terminal ileum with good prep.Normal distal most terminal ileum.Normal colon and rectum with no evidence for neoplasia colitis or diverticular disease.

Manufacturer Narrative

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

• 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: 5979393
• MDR Text Key: 55683136
• Report Number: 1030489-2016-02667
• 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
• Report Date: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510600
• Device Lot Number: M112001ABL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2016
• 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): Required Intervention