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

Catalog Number	6190052
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was pre-operatively diagnosed with non union and underwent anterior cervical discectomy and fusion (acdf) surgery at c4-7 levels.Post-operatively, the locking mechanism of the plate was broken.As a result, revision surgery was performed to remove the hardware and perform re-instrumentation.The products came in contact with the patient.No fragment of the plate remained in the patient.No patient complications were reported.
Additional Manufacturer Narrative
Post-op x-rays of c4-c7 acdf show a backed out screw at c7.Solid fusion is apparent at c5-6, less so at c6-7 peek interbody grafts were used.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis results: visual microscopic the plate was returned without any outward signs of damage.After a microscopic review of the plate, there does not appear to be any cracking.Once the screw had broken the angle between the screw head and lock could change allowing the screw to move past the lock.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: 8109379
• Report Number: 1030489-2018-01565
• Device Sequence Number: 1913553
• Product Code: KWQ
• UDI-Device Identifier: 00613994235916
• UDI-Public: 00613994235916
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K063100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2019

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 Catalogue Number: 6190052
• Device Lot Number: 0551345W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 11/27/2018; 06/26/2019
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 12/24/2018; 07/24/2019
• 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: Required Intervention
• Patient Weight: 61