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

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

Patient Problems Abdominal Pain (1685); Dysphagia/ Odynophagia (1815)

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) 2005: the patient was pre-operatively diagnosed with cervical spinal stenosis and underwent c4-c7 anterior cervical discectomy and fusion.As per op-notes, ¿after the thecal sac and nerve roots had been adequately decompressed antibody fusion grafts of peek material with bone morphogenic protein inserted into them with and was then placed into disc spaces.Seven millimeter graft was used at c4-c5.A five millimeter graft at c5-c6 and a six millimeter graft at c6-c7¿.On (b)(6) 2007: the patient was pre-operatively diagnosed with epigastric pain and dysphagia and underwent esophagogastroduodenoscopy and esophageal dilation.On (b)(6) 2008: the patient was pre-operatively diagnosed with left renal calculus and underwent the left extracorporeal shock wave lithotripsy.

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: 5979002
• MDR Text Key: 55669551
• Report Number: 1030489-2016-02664
• 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: 7510200
• Device Lot Number: M115005AAF
• 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): Other
• Patient Age: 57 YR