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U.S. Department of Health and Human Services

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

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MEDTRONIC SOFAMOR DANEK; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR Back to Search Results
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.
 
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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 Key5506432
MDR Text Key40531934
Report Number1030489-2016-00704
Device Sequence Number1
Product Code MAX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/15/2016
Initial Date FDA Received03/17/2016
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 Number1
Patient Outcome(s) Other;
Patient Age00065 YR
Patient Weight79
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