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 Neurological Deficit/Dysfunction (1982); Neuropathy (1983); Pain (1994); Weakness (2145)

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

Event Description

Pre-op diagnosis: scoliosis (6 patients), degenerative disc disease (2 patients) procedure: lateral lumbar interbody fusion (llif) it was reported in the literature titled ¿three-dimensional computed tomography-based spinal navigation in minimally invasive lateral lumbar interbody fusion: feasibility, technique, and initial results¿ that multiple patients were treated with rhbmp-2 packed into the disk space and interbody cage.Postoperative neurological deficits were recorded.Of the 8 patients analyzed, 6 were women, and the mean age was 66 years.A mean 2.8 levels were treated.Of the 22 interbody cages placed, 12 (54.5%) were placed in quarters 1 to 2 and 10 (45.5%) were placed in quarters 2 to 3.One patient had groin pain after surgery, which resolved.One more patient had bilateral thigh pain and one had right thigh pain, both of which resolved by the patients¿ 1-month follow-up visits.Another patient had a normal neurological examination after surgery but later developed diplopia followed by weakness in all of his extremities.Patient was diagnosed with a miller-fisher variant of an acute inflammatory demyelinating polyradiculo-neuropathy and was treated by plasmapheresis with subsequent complete resolution of symptoms.

• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8313585
• MDR Text Key: 135351319
• Report Number: 1030489-2019-00116
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• 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?: Yes
• Date Manufacturer Received: 02/07/2019
• 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 Age: 66 YR