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 Pain (1994); Tingling (2171); Discomfort (2330); Numbness (2415); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Neither device nor applicable imaging studies returned to manufacturer for evaluation.

Event Description

It was reported that on (b)(6) 2012, patient was involved in a mvc rollover as a restrained driver with airbag deployment.Patient reported with headache, neck pain and loss of consciousness.Patient underwent chest and pelvis x-ray and ultrasound fast exam, all of these were negative as per radiology.Ct of head showed subdural hemorrhage, along with tentorium with subarachnoid hemorrhage.Ct of c-spine was negative.Ct of t and l spine showed l1 compression fracture.And t12 burst fracture with retropulsion into the canal.On (b)(6) 2012, patient was diagnosed with t12-l1 seat belt fracture with instability, patient underwent t10-l2 spinal fusion with ins trumentation.T10, t11, l1, l2 segmental pedicle screw instrumentation.5.5mm diameter screws were placed at l1 bilaterally.6.5mm diameter pedicle screws were placed at l2 bilaterally.6.5mm diameter screws were placed at t10 and t11, t12 was skipped.Rods were placed bilaterally in lordotic position and placed into screws.Rhbmp-2 was placed in postereolateral spaces from t10 to l2 to facilitate fusion.On (b)(6) 2012, patient underwent ap and lateral x-ray of cervical, thoracic and lumbar spine which showed slight reverse spodylolisthesis of t12 over l1, due to prior trauma.There was mild kyphosis at lower thoracic spine.There was mild sigmoid curvature of thoracolumbar spine.Screws were in good position.On (b)(6) 2012, patient underwent ap, lateral x-ray of thoraculumbar spine which showed interval stability of rod and pedicel screw spinal fixation.There were mild anterior wedge compression deformities at t11, t12 and l1.No new fractures were seen and disc spaces were well maintained, pedicle and posterior elements appeared to remain intact.Impression: stable thoracolumbar spinal fixation extending from t10 through l2.There had been interval healing callus formation at levels of mild anterior wedge compression deformities from t11 through l1, demonstrating stable height and contour.On (b)(6) 2012, patient reported with numbness and tingling in fingers, stiffness, discomfort and midback pain, patient underwent x-ray of thoracolumbar spine which showed good position of instrumentation, closed fracture in thoracic vertebral body and joint instability in neck.

• 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: 5026824
• MDR Text Key: 23911981
• Report Number: 1030489-2015-02060
• 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: Other
• Report Date: 07/27/2015

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 Expiration Date: 08/01/2014
• Device Catalogue Number: 7510400
• Device Lot Number: M111063AAX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/27/2011
• 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