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 Headache (1880); Pain (1994); Vomiting (2144)

Event Type  Injury  

Event Description

It was reported that prior to (b)(6) 2007, patient had been prescribed ¿mood stabilizers¿ by her primary care physician in order to combat her depression.On (b)(6) 2007, the patient presented for significant pain in her mid-back and coccyx and numbness in her feet.On (b)(6) 2008, surgeon performed surgery consisting of a posterior spinal fusion from t10-l1 using rhbmp-2/acs.Post-op, surgeon told that he had found more broken vertebrae in her spine once the surgery had begun and that these breaks were not capable of being discovered during pre-surgery imaging procedures.Patient underwent physical therapy with dr.Durrani for her post-operative care.Neck began to swell and become painful.Surgeon told that she had ¿spinal stenosis¿ and recommended that she undergo another surgery to ¿open the vertebrae so her spinal cord would have room.¿ doctor performed surgery consisting of a laminoplasty from c3-c7 using rhbmp-2/acs.Post-op patient began suffering from severe headaches and several bouts of vomiting.Patient now suffers from worse pain in her back and neck than she did prior to his surgeries.

Manufacturer Narrative

(b)(6).(b)(4).Neither the device nor applicable medical records or imaging studies were returned nor provided for evaluation.So, cause of event cannot be determined.

• 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: 4936996
• MDR Text Key: 6011390
• Report Number: 1030489-2015-01609
• 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: 07/23/2015
• 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): Other