MAUDE Adverse Event Report: WARSAW ORTHOPEDICS ATLANTIS® ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BOD

Model Number	7200040
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)
Date of Event	09/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient, competent authority via a manufacturer representative regarding a patient with fusion therapy.It was reported that the patient had a atlantis c5-7 anterior fusion plate placed for discs protruding onto spinal cord.Patient developed autoinflammatory disorder, erythroderma swelling and edema in 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.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 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.Patient had failure of fusion - nonunion.(possibly due to the broken screw) adverse immune response to metals in the implant.
Additional Manufacturer Narrative
D4.Lot no.Is unknown.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATLANTIS® ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BOD
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 18189162
• Report Number: 1030489-2023-00793
• Device Sequence Number: 15257757
• Product Code: KWQ
• UDI-Device Identifier: 00613994625120
• UDI-Public: 00613994625120
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K021461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/22/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7200040
• Device Catalogue Number: 7200040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 11/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown