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

Catalog Number 7510100

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); Sleep Dysfunction (2517)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(revision surgery, 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 underwent spinal fusion surgery on the lumbar region of his spine from vertebrae l4 to l5 using rhbmp2 on (b)(6) 2012.Post-op patient reportedly had "increasing low back pain, with pain and radiculopathy into his right leg.Severe pain and symptoms ultimately compelled patient to undergo revision surgery on (b)(6) 2012, after imaging studies revealed ectopic bone growth.Despite revision surgery, patient continues to experience chronic back pain, with pain and burning throughout his right leg, weakness and atrophy in his right leg, and muscle spasms in his right foot.Patient also suffers from bladder and bowel issues, erectile dysfunction, 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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was preoperatively diagnosed with post-laminectomy syndrome with stenosis at l4-l5 and lower extremity radiculopathy.The patient underwent the following procedures: redo bilateral laminotomy at l4 - l5 with decompression of neural elements.Posterior spinal fusion l4-l5 with pedicle screw and rod instrumentation.Posterior lumbar interbody fusion with peek interbody cage.Case was done with fluoroscopic guidance.As per the op notes: ¿a needle used to harvest 8 ml of bone marrow for reconstituting graft.Using a high-speed drill, bilateral laminotomy was done releasing the flavum.After decompression of neural elements, a facetectomy was done on the right exposing the l4-l5 annulus.An annulotomy and diskectomy were followed by preparation of the endplates for fusion.A peek cage with rhbmp-2 sponge was impacted across the l4 -l5 disk space.The remaining disk space was filled with graft reconstituted with bone marrow, harvested earlier.The lateral gutter was decorticated.Graft was placed posterolaterally as well.The wound was irrigated.Pedicles were then tapped bilaterally over the guidewires at l4 and l5.Pedicle screws were inserted over the guidewires under fluoroscopic guidance.Also contoured lumbar rods were attached to pedicle screws through small stab wounds in the superior flank.Gentle compression was carried out across the anterior cages.Set screws were tightened down onto the connecting rod.¿ 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: 5781642
• MDR Text Key: 49124227
• Report Number: 1030489-2016-02034
• 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,Followup
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2012
• Device Catalogue Number: 7510100
• Device Lot Number: M111109AAF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/27/2012
• 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; Required Intervention