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

Catalog Number	7200023
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling (2091)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Devices of multiple part/lot numbers were implanted during the procedure including: part: 3120213 / lot: unk (x4) part: 7200023 / lot: unk (x1) although it is unknown if any of these devices contributed to the reported event, we are filing this mdr for notification purposes.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.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.
Event or Problem Description
It was reported that on (b)(6) 2015, patient had a fusion done at level c6-7.Per op notes, screws were placed in c6-7.Herniated disk material was removed from top of nerve root.A 7 mm graft was counter sunk in position at c6-7.A plate after this was placed with 13 mm screws.No intraoperative complications were reported.Post-op, patient had swelling around the area where the spine surgery was performed.
Additional Manufacturer Narrative
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 BODY
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 6248740
• Report Number: 1030489-2017-00086
• Device Sequence Number: 496766
• Product Code: KWQ
• UDI-Device Identifier: 00613994625199
• UDI-Public: 00613994625199
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2016

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
• Operator of Device: Health Professional
• Device Catalogue Number: 7200023
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2016
• Supplement Date Received by Manufacturer: 12/19/2016
• Initial Report FDA Received Date: 01/13/2017
• Supplement Report FDA Received Date: 09/28/2017
• 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