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 Weakness (2145); Burning Sensation (2146); Tingling (2171); Numbness (2415); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(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.

Event Description

It was reported that on (b)(6) 2011, patient underwent posterior lumbar interbody fusion and posterolateral fusion surgery.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the disc space and posterior elements).Reportedly, "patient's post-operative period has been marked by a period of improvement, followed by increasing low back and bilateral leg pain, and burning, numbness and sensitivity in his thighs." allegedly, "patient continues to experience chronic lower back pain, shooting pain in his groin area, numbness and tingling in his thighs, and weakness in both legs.Patient experiences difficulty sitting, standing and walking, and suffers from sexual dysfunction.".

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 the patient was pre-operatively diagnosed with lumbar recurrent stenosis with disk herniation and instability of joint, l4-l5 and underwent the following procedures: bilateral decompression laminectomy for removal of facet osteophytes and stenosis and epidural scar tissue and discectomy.Interbody arthrodesis, l4-l5.Lateral transverse process facet arthrodesis, l4-l5.Nonsegmental pedicle screw instrumentation, l4-l5.Interbody fusion cage (cage inserted in polar direction).Stealth navigation and 0-arm for surgical planning of pedicle screws and navigation for insertion of hardware.Graft source of rhbmp-2 and local bone allograft.Patient underwent mri scan prior to surgery which indicated modic instability signal.There is also recurrence of stenosis and some disk herniation.As per the op notes: ¿attention was turned towards the placement of the l5 pedicle screws, as these were felt to be difficult once to perform.Standard retraction of the muscle was attempted at various times and there was too much retraction on the instrumentation to be able to allow this to go in that direction and using this approach, the pedicle screws were going in too straight and could not be over 30 mm in length.This was followed by a pedicle probe that was tampered into position followed by a 5-mm tap.A screw was then inserted and monitoring measurements greater than 20 milliamps.In similar fashion, both the left and right l5 pedicle screws were placed, albeit with some difficulty and persistence and able to get the angle required.Next, the l4 level pedicles were identified and with navigation, these were tapped and screws placed.Attention was then turned towards the decompression where bilateral decompression was performed with drilling of the lamina and medial facet and subsequent removal with the 4-5 rongeur.The fluoroscopy was brought in and a 10 x 26 mm cage was filled with rhbmp-2/acs that had been reconstituted to manufacture specifications and tampered into place.Rhbmp-2/acs was also placed in the disk space ahead of the cage.Thus interbody fusion was completed with placement of interbody cage.Next, the lateral transverse processes and facets were decorticated with high-speed drill and graft and rhbmp-2/acs material as well as autologous bone material from the laminectomy defect was placed in the lateral gutters and over the facets and pars and interarticularis for lateral fusion mass.Rod had been placed between the l4 and l5 pedicle screws and locked in position with locking screws tightened to manufacture specifications.It should be noted that prior to placement of any of the rhbmp-2/acs products infusion, the wound had been copiously irrigated with antibiotic solution.¿ 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: 6020041
• MDR Text Key: 57057675
• Report Number: 1030489-2016-02861
• 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: 11/10/2017

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 Expiration Date: 05/01/2013
• Device Catalogue Number: 7510400
• Device Lot Number: M110915AAG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/19/2016
• Initial Date FDA Received: 10/12/2016
• Supplement Dates Manufacturer Received: 09/19/2016; 10/16/2017
• Supplement Dates FDA Received: 09/25/2017; 11/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/16/2010
• 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): Other