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

Catalog Number 7510600

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

Patient Problem Osteolysis (2377)

Event Date 09/01/2010

Event Type  Injury  

Event Description

It was reported in a publication that the authors conducted a prospective cohort study of all patients in the study period undergoing instrumented tlif.This study included 81 patients (40 men and 41 women) with a mean age of 43.5 years (range 20¿64 years) who underwent instrumented tlifs between january 2005 and may 2006.Group i (37 patients) had carbon fiber cages placed while group ii (44 patients) had 70/30 pldla cages implanted.Plain radiographs were obtained at 6 weeks, 3 months, 6 months, and 1 year to assess arthrodesis.Patients were followed for 24¿39 months.Information on patient demographics and complications during the follow-up period was recorded and analyzed.Patients underwent 1- and 2-level tlifs for one or more or the following diagnoses: ddd, scoliosis, and spondylolisthesis.Three-level tlifs were performed in 2 patients with scoliosis.One large kit of rhbmp-2/acs was divided into 1 small piece and 2 equal but larger pieces.The small piece of infuse was packed into either the hydrosorb biodegradable pldla cage or the leopard cfrp tlif carbon fiber cage (depuy spine) cage.One cage per level was then inserted into the disc space.Intraoperative fluoroscopy was used to verify appropriate placement of the cage.Bilateral segmental pedicle screw fixation and fusion was performed with posterior titanium screws at a variable number of levels above and below the level of the tlif.The sponge was placed into the interbody cage, and the rest of the 12-mg sponge was divided equally and was placed bilaterally on the decorticated transverse processes.No additional bmp-2 was placed in the disc space outside of the cage.A drainage tube was placed subfascially, and a multilayer wound closure was performed.Fusion was assessed on lateral flexion-extension films by the presence or absence of motion between 2 adjacent fusion segments and on anteroposterior and lateral radiographs by the presence of newly formed trabeculated bone between 2 adjacent fusion segments.Patients were given the diagnosis of pseudoarthrosis after 1 year if progressive bony healing had not been noted on the successive radiographs.5 of the 68 patients developed l4-5 vertebral body osteolysis after an l5-s1 tlif.

Manufacturer Narrative

Article citation: smith et al.Increased incidence of cage migration and nonunion in instrumented transforaminal lumbar interbody fusion with bioabsorbable cages.J neurosurg spine 13:388¿393, 2010.Implant date: january 2005 - may 2006.(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.Products from multiple manufacturers were implanted 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.

• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4403286
• MDR Text Key: 5121784
• Report Number: 1030489-2015-00097
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2014

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: 7510600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2014
• Initial Date FDA Received: 01/09/2015
• 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 Age: 00043 YR