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); Depression (2361); Neck Pain (2433); Sleep Dysfunction (2517)

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2010, patient underwent for an mri of the lumbar and cervical spine.The mri stated ¿at the t12-l1 and l1-l2 levels as well as the l2-l3 levels, the intervertebral discs are normal.At the l3-l4 level, there are endplate degenerative changes.There were posterior osteophytes and there were facet degenerative changes.There was no evidence for significant central canal or neural foraminal narrowing.At the l4-l5 level, there was only minimal right neural foraminal narrowing.At the l5-s1 level, the intervertebral disc is normal.There were mild facet degenerative changes.On (b)(6) 2010: patient was referred to a neurosurgeon.On (b)(6) 2011, the patient had an injury at work.And, patient underwent a ct of the cervical spine without contrast, a ct of the head without contrast, and an x-ray of the elbow left ap lateral and obliques where the impression of the x-ray of the elbow had negative findings.The impression of the ct of the head stated no acute abnormality of the brain was seen without evidence of intracranial injury.The impression of the ct scan of the cervical spine (which included axial scans throughout the cervical spine) was described as ¿a partial fusion of the c4 and c5 vertebral bodies.There was mild/moderate disc space narrowing at c5-c6 and c6-c7.No fracture was seen.No significant prevertebral soft tissue swelling was seen.There was anterior and posterior disc margin spurring, most prominent c5-c6 and c6-c7.There was moderate left-sided neural foraminal narrowing at c3-c4, moderate right-sided narrowing at c5-c6 and moderate bilateral neural foraminal narrowing at c6-c7.The final impression for the ct scan of the cervical spine on (b)(6) 2011, was degenerative changes.No fracture.On (b)(6) 2011: the patient underwent mri of the cervical spine without contrast and an mri of the left shoulder without contrast for neck and left shoulder pain.On (b)(6) 2011: the patient was assessed by the doctor with following comment- severe restriction of the cervical spine range of motion due to pain and that all movements of the neck were extremely painful.The sensory examination showed clear sensory parenthesis all the way from c6 and c7 predominantly and even somewhat c8 distribution as well.Patient's mri revealed a congenitally fused segment of c4-c5.There is a large disc herniation of c4-c4 and a large disc herniation of c5-c6 and c6-c7.The axial images show there is a complete foraminal stenosis at c6-c6 bilaterally, complete foraminal stenosis at c7-c7 bilaterally and on the c3-c4 it is on the left side.On (b)(6) 2012: the patient underwent a cervical spine surgery on c6-c7.The patient was implanted with rhbmp-2/acs.Post-op, patient allegedly developed severe headaches.And, patient also underwent mri.On (b)(6) 2012: the patient underwent cervical spine surgery on c3-c4.The patient was implanted with rhbmp-2/acs.On (b)(6) 2012: patient was rushed to er due to severe leg pain and trouble walking.Currently patient alleges that he is now permanently disabled, disfigured, harmed, immobile and in constant pain.He continues suffer ing to this day from severe neck pain, back pain, radiating arm pain and headaches.He does not sleep and at times becomes severely depressed.He does not function the way he once did before surgery.

Manufacturer Narrative

(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: 4966061
• MDR Text Key: 15129576
• Report Number: 1030489-2015-01905
• 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: 08/04/2015
• 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