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

Catalog Number 7510800

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

Patient Problems Unspecified Infection (1930); Neuropathy (1983); Pain (1994); Numbness (2415)

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2007 ¿ post-op an anterior and posterior l3-s1 fusion, the patient developed cauda equina syndrome with complete paralysis in both lower extremities.He then did recover and had continued weakness but was able to ambulate.He had a severe left radiculopathy, which was untreated by conservative measures and severe back pain.Imaging revealed a pseudoarthrosis at l3-l4 and l5-s1 with 1 pedicle screw in s1.The left l3 screw was a medial bridge into the spinal nerves and into the canal, and there was no posterior lateral fusion identified on imaging.On (b)(6) 2007 ¿ pt.Presented to surgery status post l3-s1 fusion with anterior and posterior instrumentation; l3-4, l4-5 pseudoarthrosis; left l3 pedicle screw malplacement; cauda equine syndrome.Pt.Underwent a procedure for removal of hardware l3-s1; exploration of fusion l3-4-5-s1; l3-s1 posterolateral fusion; right iliac crest bone marrow aspirate; scar revision.Iliac bone marrow aspirate was mixed with morseslized allograft and bmp and placed in the lateral gutters bilaterally at l3-s1.Cd horizon legacy titanium posterior fixation l3-s1.On (b)(6) 2007 ¿ ¿patient has an infection in the top of his wound following his back surgery, a very small area over the skin is open and leaking serous sanguinous fluid.The patient has no associated abscess or swelling.No fever.No surrounding erythema.Will treat with doxycycline¿ (b)(6) 2008 ¿ pt.Continues to have chronic right leg pain.Not working due to severe leg and back pain.X-rays show no evidence of pseudoarthrosis.On (b)(6) 2008 ¿ ct of lumbar spine shows extensive lower lumbar postoperative changes with apparent good alignment and appearance.There is no identifiable pathology seen with visualization in the low lumbar spine significantly limited by the adjacent metallic hardware.On (b)(6) 2008 ¿ ¿pt has great control of low back pain with multiple modalities but still needs tens unit, physical therapy, and drug management to maintain control.¿ on (b)(6) 2008 ¿ ¿patient low back pain and numbness and tingling in the right leg are all under reasonably good control on existing therapy.¿ on (b)(6) 2009 ¿ pt.Has ongoing back pain and right leg pain.Pain radiates down the right leg to the bottom of the foot.Pt.Describes burning pain, numbness, and some weakness.There is electrodiagnostic evidence of right l5 and s1 radiculopathy.There is evidence of chronic active denervation of in the right s1 distribution.There is some evidence of proximal reinnervation but still marked denervation in the most proximal muscles.In the l5 distribution, there is still evidence of marked denervation distally.There is evidence of reinnervation more proximally.Overall findings are not quite as marked at that in the s1 distribution.On (b)(6) 2009 ¿ pt.Underwent a procedure for caudal equine injection to treat right l5 and s1 radiculopathy.On (b)(6) 2009 ¿ pt.Underwent procedure for s1 selective nerve root block to treat right l5 and s1 radiculopathy.On (b)(6) 2009 ¿ mri lumbar spine impression: hypointense collection dorsal to the thecal sac, extradural in location, along the dorsal aspect of the spinal canal; signal intensity as above, predominantly markedly hypointense.The appearance is most suggestive of a small amount of iatrogenically placed air.This is not the typical appearance of an epidural hematoma.A secondary and less likely consideration is a dural arteriovenous malformation, however, in reviewing patient's exam from 2006, which included the upper lumbar region, no similar abnormality was seen.On (b)(6) 2009 ¿ ¿patient does have significant ongoing low back and leg pain, symptoms have resulted in disability and persistent limitation to level of function.¿ on (b)(6) 2010 ¿ radiology impressions: ¿no acute pathology is appreciated.¿ on (b)(6) 2009 ¿ pt.Underwent procedure for implant of one spinal neurotransmitter lead.On (b)(6) 2012 ¿ pt.States his pain is generally well controlled.His activity level includes gardening, going to the beach, swimming and camping.He has not been to the gym recently, but he has been walking and doing a little bit of biking as well.On (b)(6) 2012 - the patient presents for a follow-up.Pt.States that his pain is fairly well controlled.He states a pain score of 4 on a 0-10 scale.The patient states he has been exercising and working out with his daughter and he has been active with his children and maintaining the household.

Manufacturer Narrative

(b)(6).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.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.

• 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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4245491
• MDR Text Key: 20975654
• Report Number: 1030489-2014-04356
• 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
• Report Date: 10/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2009
• Device Catalogue Number: 7510800
• Device Lot Number: M110608AAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2014
• Was Device Evaluated by Manufacturer?: No
• 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