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

Catalog Number	6190062
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported that on (b)(6) 2017, patient underwent cervical corpectomy procedure at level c5-t1 due to pre-op diagnosis as c5 fr acture.Reportedly, on an unknown date, post-op, the plate broke and the graft was loose.Whether any fragments remained in patient or not was unknown.The patient had not achieved solid fusion as it was too early for fusion.The patient underwent additional surgery on (b)(6) 2017.The broken plate was removed and the graft was adjusted to fill the gap and a new plate was implanted.Patient had no injury post the revision surgery.
Additional Manufacturer Narrative
Product analysis: visual review confirms implant disassembly.Visual and microscopic examination identified fracture and associated deformation on the anterior face of both end components, consistent with significant bending stresses.This deformation could have provided an escape path for the end component ratchet springs, resulting in subsequent disassembly.
Additional Manufacturer Narrative
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 BODY
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 6342643
• Report Number: 1030489-2017-00337
• Device Sequence Number: 650656
• Product Code: KWQ
• UDI-Device Identifier: 00613994235695
• UDI-Public: 00613994235695
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2017

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: 6190062
• Device Lot Number: 0381321W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Initial Date Received by Manufacturer: 01/25/2017
• Supplement Date Received by Manufacturer: Not provided; 05/19/2017
• Initial Report FDA Received Date: 02/20/2017
• Supplement Report FDA Received Date: 06/12/2017; 09/29/2017
• 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: Required Intervention
• Patient Age: 40 YR