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

Catalog Number 7510800

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

Patient Problems Ossification (1428); Nerve Damage (1979); Pain (1994); Stenosis (2263); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported that on: (b)(6) 2010: the patient presented with l3-l4 degenerative disk disease and stenosis with l4-l5 and l5-s1 anterior inter-body non-union and underwent the following procedures: removal of the anterior cage implants.L3-l4, l4-l5 and l5-s1 anterior inter-body fusions.Femoral ring allografts l3-l4, l4-l5 and l5-s1.Anterior instrumentation l3-l4 and l5.L3-l4 laminectomy.Bilateral l5 foraminotomies.L3 to sacrum posterior segmental instrumentation.Bilateral iliac screw supplemental fixation.L3-l4, l4-l5 and l5-s1 posterolateral fusions.Local bone graft plus rhbmp-2/acs.As per-op notes, ¿¿the left-sided previously placed pedicle screws at l4-l5 and s1 were disassembled and the rods and screws were removed.Pedicle screws were placed bilaterally in the l3-l4, l5 and s1 pedicles and in the intra-iliac location.L3-l4 laminectomies were performed.Both l5 nerve roots were decompressed¿.At each level trial spacers were placed and ultimately at the l5-s1 and the l4-l5 levels, 16 mm lordotic femoral ring allografts were placed.These contained rhbmp-2 soaked sponges.Diskectomy was performed at l3-l4 levels.A 14 mm graft was placed¿.Rhbmp-2/acs soaked sponges were then placed laterally spanning these decorticated posterior elements¿¿ on (b)(6) 2013: the patient presented with lumbar pseudoarthrosis, l2-l3 and l3-l4 along with lumbar stenosis and spondylosis.Failed back syndrome and underwent the following procedures: removal of retained hardware.Re-instrumentation of retained hardware at l2-l3 and l3-l4 with pedicle screw instrumentation using spinal usa pedicle screws.Exploration of the fusion mass.L2-l3, l3-l4, l4-l5 decompression and l5-s1 decompression.Neuro-monitoring throughout the procedure.Post-op fusion l2-l3 and l3-l4 with pedicle screw instrumentation and use of autograft and allograft.

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: 5672437
• MDR Text Key: 45688738
• Report Number: 1030489-2016-01483
• 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
• Report Date: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2013
• Device Catalogue Number: 7510800
• Device Lot Number: M110909AAI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2010
• 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