MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Catalog Number 7510400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Bone Fracture(s) (1870); Spinal Column Injury (2081)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).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) 2002 the patient was admitted due to l1 burst/compression vertebral body and pedicle fracture with instability, kyphosis and canal compromise.She underwent the following procedure: decompressive laminotomy t12-l1 through l1-2; resection of epidural, repulsed, bone fragments of l1.Deformity correction and bilateral pedicle screw fixation t11 through l2.Review of systems: psych: benign.The patient underwent a ct of the lumbar spine which revealed an l1 burst fracture and left pedicle fracture with retropulsed bone fragments and approximately 70 percent canal compromise.Assessment: l-1 burst and pedicle fracture with marked canal compromise, two "clumn" unstable injury, neurologically intact; tobacco use; obesity.On (b)(6) 2002 the patient presented with l1 burst/compression vertebral body and pedicle fracture with instability, kyphosis and canal compromise.The patient underwent the following procedures: decompressive laminectomy t12-l1 through l1-2; foraminotomy t12-l1 through l1-2; resection epidural (retropulsed) bone fragments l1; deformity correction t11 - l2; computer assisted frameless stereotactically guided instrumentation; bilateral pedicle screw fixation t11 through l2 with rods and crosslink; arthrodesis posterolateral t12 through l1; fusion with morselized (non-structural).Autograft, morselized allograft, bone morphogenic protein, autologous growth factor; placement ebi two lead internal bone growth stimulator.Per op notes- the posterolateral bony surfaces were arthrodesed using the match head burr on the air drill.Pedicle screws were then placed along the previously marked trajectories, radiographs taken to confirm positioning, and the screws were interconnected using bilateral rods and necessary cross-links.Autologous growth factor was used to saturate the allograft and autograft harvested from the laminae and spinous processes as well as the epidural space at l1.The bone graft was then combined with rhbmp-2/acs and placed along the l1 pedicle screw trajectories (prior to screw placement) and posterolaterally along the arthrodesed bony surfaces along with braided leads of the bone growth stimulator.On (b)(6) 2002 the patient was discharged following l1 burst/compression vertebral body and pedicle fracture with instability, kyphosis and canal compromise.Facet disruption t12-l1.Impression: l1 compression fracture, status post decompression, obesity, tobacco dependence, hyponatremis, bradycardia resolved, osteoporosis, constipation.On (b)(6) 2002 the patient was discharged with the following diagnosis: multiple trauma status post decompression and fusion t11 through l2.On (b)(6) 2014 the patient got an mri of the lumbar spine done.Impression: bone stimulator, equivocal for mri compatibility, should be done at a facility that has lower tesla unit or open unit, with appropriate local backup support; degenerative spinal changes; osteoporosis.

• 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: 5160214
• MDR Text Key: 28720993
• Report Number: 1030489-2015-02738
• 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
• Report Date: 09/21/2015

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
• Device Catalogue Number: 7510400
• Device Lot Number: MA111004D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2015
• 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
• Patient Weight: 89