MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number UNKNOWN

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

Patient Problems Neuropathy (1983); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Multiple products used in the event.It is known which product caused the event.Product id: 2922245, lot number: 51au, quantity: 1; product id: 2968045, lot number: 49am.Quantity: 1; product id: 2922255, lot number: 06as, quantity: 1; product id: 2153116, lot number: 75ac, quantity: 1.X-ray analysis: patient presented with ligament disease.She had an extensive fixation for l2-s1 including multilevel oblique plate and cages.Patient still had back pain at time of complaint.2-3 months post op there is no problem identified with hardware on post op x-ray.Root cause surgical technique / patient factors.Product was not 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) 2015: patient was diagnosed with radiculopathy.Motor deficit- l2 to s1: 5(both left and right).Sensory deficit- left l4 and l5: incomplete.Patient was diagnosed with disc herniation at l1-l2(protruded), l4-l5(protruded), l5-s1(protruded).Disc degeneration at l1-l2, l2-l3, l3-l4, l4-l5, l5-s1.Miltilevel discopathies at l5-s1.Spinal stenosis at l4-l5(central).Spondylolisthesis at l4-l5(grade 1).Patient presented with the history of hypertension.It was reported that on an unknown date, post-op, patient complained of left and right sacroiliac joint pain.As per the doctor, it was related to the fixation (stablization) system and the plates related to probable stress from anterior/posterior construct.On (b)(6) 2016: patient presented for follow-up.On (b)(6) 2016: patient presented with right and left sensitive radiculopathy.

• Brand Name: UNK
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5506432
• MDR Text Key: 40531934
• Report Number: 1030489-2016-00704
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2016
• 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): Other
• Patient Age: 00065 YR
• Patient Weight: 79