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 Problem Incontinence (1928)

Event Type  Injury  

Event Description

It was reported that patient was experiencing testicular pain.On an unknown date the patient was diagnosed with congenitally short pedicle syndrome and central spinal stenosis.The patient underwent epidural injections to treat pain.On (b)(6) 2009, the patient underwent following procedures:(1) a laminal osteotomy from l2-l5; (2) a spinal fixation from l2-l5; and (3) a foraminotomy from l2-l3 and l3-l4.The patient was implanted with rhbmp-2/acs.After three months, in (b)(6) 2009, the patient was suffering from significant neck pain and was diagnosed with very large disc herniation.On (b)(6) 2009,the patient underwent following procedures:(1) an anterior cervical discectomy and fusion from t1-t2; (2) an anterior thoracic discectomy from t1-t2; (3) placement of an anterior thoracic cage from t1-t2; and (4) an anterior thoracic fusion from t1-t2 using auto and allograft.The patient was implanted with rhbmp-2/acs.After the second surgery the patient experienced odd ¿popping¿ sensations in neck and shoulders, but experienced no other pain.On (b)(6) 2010,the patient underwent following procedures:(1) a vat discectomy from t6-t7 and t7-t8, (2) an anterior interbody fusion from t6-t7 and t7-t8 using auto and allograft, (3) placement of anterior interbody cages from t6-t7 and t7-t8, (4) posterior spinal instrumentation from t6-t7 and t7-t8, and (5) a posterior spinal fusion using auto and allograft from t6-t7 and t7-t8.The patient was implanted with rhbmp-2/acs.On (b)(6) 2010 the patient suffered from mild incontinence.On (b)(6) 2010,the patient underwent following procedures:bilateral percutaneous instrumented facet fusion from l5-s1.The patient was implanted with rhbmp-2/acs.The patient experienced incontinence, depression, and severe pain.The patient existed in a state of near-constant pain.By the end of the day, patient legs and feet were so swollen that he could not stand.The patient also developed difficulty in swallowing, and frequently suffered fits of coughing and choking.

Manufacturer Narrative

(b)(6).(b)(4).Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the 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: 4946769
• MDR Text Key: 6636408
• Report Number: 1030489-2015-01725
• 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: 07/28/2015
• 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