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

Catalog Number 7510200

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

Patient Problems Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Weakness (2145); Burning Sensation (2146); Tingling (2171); Anxiety (2328); Depression (2361); Numbness (2415); Sleep Dysfunction (2517); 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.Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes.

Event Description

It was reported that on (b)(6) 2014, patient underwent anterior lumbar interbody fusion surgery on the lumbar region of her spine from vertebrae l5 to s1.Reportedly, the patient was implanted with rhbmp-2/acs in this surgery.Allegedly, " patient's post-operative period has been marked by a period of improvement, followed by progressively worsening low back pain with radiating pain down both legs to her feet, weakness in her legs, and burning, numbness and tingling in her feet." reportedly, " the patient continues to experience chronic lower back pain, with shooting pain radiating down her left side to her feet, weakness in both legs, muscles spasms on her left side, and numbness, tingling and burning sensations in left her foot.Plaintiff cannot sit for any length of time or walk any extended distance.Plaintiff also suffers from depression, anxiety and difficulty sleeping.".

Manufacturer Narrative

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.

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 l5-s1 spondylolisthesis disc collapse and stenosis with low back, radicular leg pain, weakness and sensory loss and underwent the following procedures: anterior lumbar discectomy and interbody fusion, placement of intervertebral biomechanical device l5-s1, placement of non-segmental anterior instrumentation at l5-s1 in which rhbmp-2/acs was used.As per op-notes, "we elevated the disk heights using a series of blunt dilators and then continued to work posteriorly.We performed a direct decompression of the neural foramen using angled curettes and 2 mm kerrison to which we could pass the nerve hook into the neural foramen without obstruction.We irrigated and debrided meticulously with a complete discectomy done.We then trialed using out 12 mm height, 12 mm lordosis, and excellent fit within the disk space, ideal restoration of the foraminal height in the lumbar lordosis.We then removed the trial.We irrigated debrided once more.We checked the canal for any foreign material and then ultimately impacted our cage in to place.We then placed our instrumentation.When the cage was perfectly located, instrumentation placed using an awl ball-tip tap, ultimately 4 mm x 25 mm screws, which were carefully locked into position safely and ef fectively.This required an additional 30 minutes of time to perform successfully.At this point, we saved out primary final radiographs demonstrating the effectiveness of the positioning, the prominence of the disk height; lumbar lordosis, etc.We then irrigated and debrided.We carefully and sequentially removed the retractor blades taking great care to be very focused as far as verifying the absence of any bleeding, there was none." 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
• MDR Report Key: 6208004
• MDR Text Key: 63357873
• Report Number: 1030489-2016-03569
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2016
• Device Catalogue Number: 7510200
• Device Lot Number: M111301AAB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other