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

Catalog Number	6190045
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
Procedure (initial surgery): anterior cervical discectomy and fusion (acdf) with plating.Levels implanted: c3-c4; c4-c5 procedure (revision surgery): removal of existing construct, with revision and instrumented fusion of existing and additional levels.It was reported that on an unknown date, post -op, cephalad screw backed-out and non union was suspected.Due to which patient underwent an additional surgery on (b)(6) 2017 in which cervical plate and screws were removed.During dissection, surgeon discovered that cephalad locking mechanism was no longer attached to the plate.Surgeon removed locking mechanism, next he removed partially backed out screw and then the remaining screws and plate.The entire plate/screw construct was ex-planted, inspected and accounted for.The product came in contact with patient.Patient had continued degenerative disk disease (ddd) symptoms.
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.
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: 6379659
• Report Number: 1030489-2017-00461
• Device Sequence Number: 18970753
• Product Code: KWQ
• UDI-Device Identifier: 00613994235886
• UDI-Public: 00613994235886
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K063100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/08/2017

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: 6190045
• Device Lot Number: 0157122W
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2017
• Supplement Date Received by Manufacturer: Not provided; 02/08/2017
• Initial Report FDA Received Date: 03/06/2017
• Supplement Report FDA Received Date: 03/06/2017; 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: 51 YR
• Patient Weight: 74