MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. MEDTRONIC DANEK 'ATLANTIS VISION ELITE' PLATE; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number 7200040

Device Problems Break (1069); Entrapment of Device (1212); Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Dysphagia/ Odynophagia (1815); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924); Spinal Column Injury (2081); Foreign Body In Patient (2687); Intervertebral Disc Compression or Protrusion (4524); Swelling/ Edema (4577)

Event Date 09/09/2020

Event Type  Injury  

Event Description

Had a medtronic atlantis c5-7 anterior fusion plate placed at loyola mds center for discs protruding onto spinal cord.2 problems occurred 1.Autoinflammatory disorder i developed erythroderma swelling and edema in my tissues and skin which has not resolved and found to be allergic to two of the implant metals - nickel and titanium.There was also local swelling causing dysphagia and abnormal swelling and thickening of tissue in front of the device behind the upper esophagus on ct scan.There was no preop counselling on metal allergy or guidance on preop metal patch testing.The plate was removed.(b)(6) 2022 at (b)(6) hospital - see next paragraph 2 the medtronic plate and screws were planned for removal due effects of systemic metal allergy to the device components causing local and systemic allergic reaction with multiorgan impairment.Preop imaging (b)(6) 2022 showed a broken fixation screw in the c7 vertebra and perioperatively after the plate was removed the fusion was found to be mobile - ie the c5-7 fusion had failed and my cervical spine is now unstable.The broken screw will have contributed to fusion failure.The broken screw had to be left in situ as there was no safe way to remove it.So reporting 3 issues 1.Broken hardware - fixation screw 2.Failure of fusion - nonunion.(possibly due to the broken screw) 3.Adverse immune response to metals in the implant - this device may need patients to have pre op counselling and possibly testing for metal allergies before implantation.Thank you, (b)(6).

• Brand Name: MEDTRONIC DANEK 'ATLANTIS VISION ELITE' PLATE
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.
• MDR Report Key: 17906691
• MDR Text Key: 325444818
• Report Number: MW5146769
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 7200040
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ADVAIR INHALER.; ALENDRONATE.; ASPIRIN 81MG.; CETIRIZINE.; CLONAZEPAM.; CYCLOSPORINE EYE DROPS.; FAMOTIDINE.; FENOFIBRATE.; FLEXERIL.; HYDROCORTISONE ORAL.; LEVOTHYROXINE.; LYRICA.; MAGNESIUM OXIDE.; MONTELUKAST.; MULTIVITAMIN.; MULTIVITAMIN.; OXYCODONE.; ROSUVASTATIN.; VALSARTAN.; VENTOLIN INHALER.; VITAMIN D 5000IU DAILY.; VITAMIN D.
• Patient Outcome(s): Other; Disability; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White