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

Catalog Number	7200042
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Headache (1880); Inflammation (1932); Pain (1994); Increased Sensitivity (2065)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Below additional products were also implanted during the procedure.Although it is unknown which of the devices contributed to the reported event, we are filing this mdr for notification purposes.Product id , lot , 510k , upn , quantity ;3120513 , unk , k063100 , (b)(4) ,6.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that patient underwent surgery on (b)(6) 2013.Post-op, patient was in chronic pain.Patient has reportedly pain in neck, thoracic and back which has progressed throughout the body.Patient is sensitive to nickel and the sensitivity is all time high.Patient also reported to have itching and has hives due to this allergy.Patient reported gastro issues, major inflammation all over patient's body, extreme fatigue, severe headaches, sensation of electricity that feels like it is burning & sharp pain, extreme fatigue, do not feel right and many other symptoms.

• Brand Name: ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 7501735
• Report Number: 1030489-2018-00660
• Device Sequence Number: 122371
• Product Code: KWQ
• UDI-Device Identifier: 00613994625113
• UDI-Public: 00613994625113
• Combination Product (Y/N): N
• PMA/510(K) Number: K021461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/10/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 7200042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 05/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other