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 Problems Muscle Spasm(s) (1966); Neuropathy (1983); Burning Sensation (2146); Cramp(s) (2193); 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.Multiple products 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.

Event Description

It was reported that on (b)(6) 2013, the patient underwent an anterior lumbar interbody fusion surgery on the lumbar region of her spine form vertebrae l5-s1."the rhbmp-2 collagen sponge was used in the surgery.The rhbmp-2 collagen sponge was placed outside a cage(i.E in the disc space)".Post-op patient allegedly had " increasingly severe lower back and right leg pain and burning." on (b)(6) 2013, revision surgery was performed and implantation of a spinal cord stimulator in (b)(6) 2015 due to severe pain and symptoms.Reportedly the patient continues to " experience chronic lower back pain, radiculopathy in her lower extremities, and muscle spasms and cramping in her back and legs.She is unable to walk for prolonged periods and occasionally requires use of a cane or walker to assist in ambulation.She requires assistance with dressing and bathing, household chores.Patient was extremely independent, but now needs help with everything.".

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

It was reported that on: (b)(6) 2013: the patient was pre-operatively diagnosed with l5-s1 degenerative disc disease.Diabetes mellitus and underwent the following procedures: l5-s1 anterior lumbar interbody fusion using peek demineralized bone matrix and rhbmp-2.Insertion of interbody device l5-s1 (corelink foundation peek).Application of anterior spinal instrumentation l5 (syntheses using titanium washer and depuy bowtie screw).Retroperitoneal approach to the anterior lumbar spine for fusion.L5-s1 posterior spinal fusion using allograft.L5-s1 posterior spinal fusion (stryker xia).As per op-notes,¿ the endplate's of l5-s1 were freshened up, that is they were further decorticated and defects made into the endplate's to allow for the flow of bone marrow.Simultaneous to this, a large rhbmp-2 kit was prepared.Several trial spacers were inserted and ultimately a 13 mm high by 13 degree lordotic small stature cage inserted.Two bmp sponges were wrapped around demineralized bone matrix ((b)(4)).These were then packed posteriorly along the annulus fibrosis.The remaining 4 bmp sponges were also wrapped around some demineralized bone matrix and packed into our cage.Our cage was then impacted into placed under fluoroscopic guidance with good purchase obtained.Ultimately, ap and lateral fluoroscopy was used to gauge adequacy of our implant placement.¿ the patient tolerated the procedure well without any intra-operative 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: 6025389
• MDR Text Key: 57251635
• Report Number: 1030489-2016-02885
• 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: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: 7510600
• Device Lot Number: M111111AAG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/13/2012
• 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): Required Intervention