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 Incontinence (1928); Muscle Spasm(s) (1966); Numbness (2415); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

Procedure: posterior spinal fusion levels implanted: l3-s1 approach used: posterior surgical approach it was reported that patient was experiencing occasional spasms in his back that were being treated with pain medication.On (b)(6) 2010, the patient underwent posterior spinal fusion with the installation of hardware from l3-s1.The patient was implanted with rhbmp-2/acs.On (b)(6) 2010, patient went to emergency room due to severe spasms in his back.Where patient was given two injections into his hip and sent home.Within 24 hours, patient was rushed back to the hospital in extreme and excruciating pain.Patient was kept in hospital for a week.During this week, patient was also treated for severe dehydration and an infection of his surgical incisions.During follow-up period, patient reported suffering numbness in his feet as well as pain that radiated down into his legs.Six months later, patient alleged of still experiencing numbness and pain.Patient alleged that he is largely immobile and unable to engage in everyday activities.Also, patient's left leg is occasionally non-responsive and must be dragged along as he walks.Both of patient legs occasionally give out, causing falls and extreme balance issues, which he has attempted to correct by using a cane.Post surgery, patient alleged that he is also no longer in control of his bowels, and he has likewise lost the ability to engage in marital relations.His back continuously spasms, and is no longer able to work.

Manufacturer Narrative

(b)(6).(b)(4).Neither device nor applicable imaging studies returned 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: 4930874
• MDR Text Key: 6013385
• Report Number: 1030489-2015-01556
• 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

• 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
• Initial Date Manufacturer Received: 07/06/2015
• Initial Date FDA Received: 07/22/2015
• 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