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); Neuropathy (1983); Loss of Range of Motion (2032); Injury (2348); Numbness (2415); Neck Pain (2433); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4) (revision surgery) 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.Note: multiple product were used during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.

Event Description

It was reported that the patient underwent two spinal fusion surgeries using rhbmp-2/ acs in a posterolateral thoracolumbar fusion surgery and a posterior cervical fusion surgery.On (b)(6) 2006, patient underwent the spinal fusion surgery at t4-l2 levels of her vertebrae.The rhbmp-2 was used to fuse more than one level of the spine using posterior approach.The rhbmp-2 collagen sponge was placed outside a cage in the posterior elements.

Manufacturer Narrative

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.

Event Description

It was reported the patient was pre-operatively diagnosed with fixed sagittal imbalance, grossly positive sagittal balance/imbalance, status post multiple laminectomies, fusions, and instrumentations from l1 to the sacrum.Adjacent segment disease at t12-l1,marked thoracolumbar kyphosis and underwent the following procedures: posterolateral spinal fusion from t4 to l2, degenerative kyphotic segments, seven thoracic segments, two lumbar segments, nine segments total, removal of pedicle screw implants from l1 to l3, six pedicle screws, two rods, exploration and fusion from l1 to l3.Revision of posterior segmental spinal instrumentation t4 to l3, pedicle screws all levels, multiaxial screws all levels, twenty-four screws, two rods, 168 milligrams of rhbmp-2, twenty-eight sponges, 140 milliliters of graft, 40 milliliters of local bone graft.Aggressive harvesting of local bone graft, spinal cord monitoring.As per op-notes,¿ surgeon used fourteen kits of bone morphogenic protein.I believe the total dosage was 168 milligrams.The 2 milligrams per milliliters concentration.This generated twenty-eight rolled sponges/fajitas.Each fajita was an acs sponge wrapped over a crm sponge.All soaked in a total bmp.Soaked for over an hour, then converted to a stew and combined with the local bone graft.So the ultimate construct was twenty-four pedicle screws, all multiaxial, two rods 5.5, stainless steel, and then twenty-eight fajitas converted to a stew, 168 milligrams of bone morphogenic protein.Forty milliliters of local bone graft, and 140 milliliters of graft.We did extensive decortication first with lexxel and then with a curved osteotome and a mallet, and all the inner laminar spaces and the lateral transverse processes as well, t11, t12, in particular, out to the tips of the transverse processes at l1 and l2.Then placed the bone graft mixture from t4 to l2.We tightened down and sheared off all the set screws.We decided not to place any cross-links.The construct seemed stable.Actually, the quality of the patient's bone was quite good.She did not appear osteoporotic.We had to work a little bit to get the thoracic pedicle screws in.Her bone was fairly hard actually.¿ the patient tolerated the procedure well without any intra-operative complications.

• 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: 5546786
• MDR Text Key: 41823840
• Report Number: 1030489-2016-00935
• 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: 10/26/2017

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: 7510800
• Device Lot Number: M115008AAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 04/05/2016
• Supplement Dates Manufacturer Received: 03/10/2016; 10/09/2017
• Supplement Dates FDA Received: 09/20/2017; 10/26/2017
• 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): Required Intervention