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 Pneumonia (2011); Loss of Range of Motion (2032); Inadequate Pain Relief (2388)

Event Type  Injury  

Event Description

It was reported that in oct 2011, the patient consulted for terrible back.On (b)(6) 2011 the patient underwent low back surgery consisting of a lateral interbody discectomy at t12-l1, l1-l2, l-2-l-3, l3-l4, and l4-l5, and placement of direct lateral interbody cage t12-l1, l1-l2, l-2-l-3, l3-l4, and l4-l5.Rhbmp-2 was implanted in this procedure.Following the surgery, patient remained in the hospital for 15 days and developed pneumonia.She also experienced decreased flexibility in her back and was experiencing the same, if not worse pain than she experienced before undergoing her surgery.

Manufacturer Narrative

(b)(4).Neither the device nor applicable medical records or imaging studies were returned nor provided for evaluation.

• 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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4955374
• MDR Text Key: 6190585
• Report Number: 1030489-2015-01788
• 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
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• 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
• Date Manufacturer Received: 07/06/2015
• 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