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 Neuropathy (1983); Pain (1994); Tingling (2171); Depression (2361); Numbness (2415); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4) (persisting back pain).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.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 the patient was admitted to the hospital on (b)(6) 2011 and underwent spinal fusion surgery where rhbmp-2 was used.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the posterolateral gutters).Post-op, patient had increasing low back pain, with pain extending into her left buttock, groin, and left thigh.Patient continues to experience constant and extreme low back pain, pain radiating to her hips and down to her knees, and numbness and tingling in her right leg.Patient requires use of a cane to assist in ambulation and a walker or wheelchair for longer distances.Patient also experiences bladder issues and depression.

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 that on (b)(6)2011, the patient was pre-operatively diagnosed with lumbar spinal stenosis, l3-4, status post l4-5 and l5-s1 laminectomy and fusion and underwent the following procedures: 1) lumbar laminectomy l3-l4.2) removal of instrumentation l4-l5 and l5-s1.3) posterior lumbar interbody fusion using interbody cage and rhbmp-2 containing sponges.4) posterolateral arthrodesis using local autograft and rhbmp-2 containing sponges.5) pedicle screw stabilization at l3-l4 using expedium pedicle screws.As per op-notes,¿ the disk annulus was incised with an 11-blade and disk material was removed using kerrisons and pituitary rongeurs.The concorde bullet interbody cage was then selected and was a size 10-mm cage.This was packed with local autograft and emf-containing sponges and placed in the interspace.There appeared to be a tight fit.Fluoroscopy was used to confirm proper placement of the pedicle screws and the interbody device.The pedicle screws were then connected with titanium rods and a crosslink connector was placed as well.The epidural catheter was placed.The wound was irrigated with 3 l of bacitracin-containing solution.The transverse processes were decorticated with the anspach drill.Emf-containing sponges, local autograft, and the mosaic bone graft extender were then placed in the posterolateral gutters.The medium hemovac drain was placed.Hemostasis was established with bovie cautery.¿ the patient tolerated the procedure well without any intraoperative 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: 5768522
• MDR Text Key: 48711202
• Report Number: 1030489-2016-01983
• 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: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2014
• Device Catalogue Number: 7510400
• Device Lot Number: M111064AAS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2011
• 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