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 Anemia (1706); Neuropathy (1983); Pain (1994); Stenosis (2263); Depression (2361); Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

It was reported that on (b)(6) 2006 the patient underwent thoracic laminotomy t6-7 with foraminotomies.Posterior segmental instrumentation t5-6, t6-7, t7-8.Posterior fusion t5-6, t6-7, t7-8.Preoperative diagnosis: thoracic herniation with stenosis.Per-op notes: "irrigation was performed.Then, the breakoff screws were broken off.Bone morphogenic protein was mixed with hydroxyapatite and placed in the midline, and a single 03 crosslink was put into place and tightened and torqued to the appropriate foot-pounds of pressure.Irrigation was performed".On (b)(6) 2007 the patient was presented for office visit for surgical intervention.Impressions: cervical pain, low back pain, cervical radiculopathy, instability, cervical herniated nucleus pulposus.6) depression.Current nicotine abuse.Gastroesophageal reflux disease.On (b)(6) 2007 the patient underwent: anterior cervical discectomy, c5-6; anterior cervical interbody fusion c5-6; implantation of peek spacer c5-6; anterior cervical plating c5-6.Preoperative diagnosis: herniated disc, c5-6.On (b)(6) 2007 the patient was presented for office visit with low back pain with lumbar radiculopathy.Impressions: herniated nucleus pulposus, instability, degenerative disc disease, lumbar radiculopathy, low back pain, gastroesophageal reflux disease.Anemia, allergic rhinitis.Chronic nicotine abuse.The patient underwent x rays of the lumbar spine.Impression: plain x rays showed anterolisthesis of l4 on l5.Mri showed a large disc herniation at l4-5, with degenerative disc disease at l5-s1.

Manufacturer Narrative

(b)(4) (persisting back pain, disc herniation).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6043093
• MDR Text Key: 57917608
• Report Number: 1030489-2016-02943
• 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,Followup,Followup
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• 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: 09/26/2016
• 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
• Patient Weight: 68