MAUDE Adverse Event Report: WARSAW ORTHOPEDICS BRYAN CERVICAL DISC SYSTEM; PROSTHESIS, INTERVERTEBRAL DISC

Catalog Number	6470317
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Neck Pain (2433); No Code Available (3191)
Date of Event	12/21/2016
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) 2016, patient presented with pre-operative diagnosis: degenerative disc disease.For which patient under went artificial disc replacement (adr) procedure.Post-op, on an unknown date, patient presented with neck pain.The implant migrated anteriorly.For which, patient underwent revision surgery on (b)(6) 2016.
Additional Manufacturer Narrative
Analysis: visual and optical examination of the implant identified multiple cuts to the sheath, which appears to have been created by sharp object, consistent with iatrogenic damage.Additionally, one of the flanges are broken off and not returned for analysis.Dimensional examination confirmed conformance of implant overall dimensions.Microscopic examination of the shell sintered porous coating identified evidence of boney in-growth, consistent with implant located stationary for a some period of time.A search of the complaint database did not identify any additional complaint returns with this part/lot# combination.Unable to determine root cause of implant migration from the available information.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: BRYAN CERVICAL DISC SYSTEM
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 6253002
• Report Number: 1030489-2017-00109
• Device Sequence Number: 43034
• Product Code: MJO
• UDI-Device Identifier: 00613994181237
• UDI-Public: 00613994181237
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P060023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2017

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 Expiration Date: 12/09/2020
• Device Catalogue Number: 6470317
• Device Lot Number: 0442152W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Initial Date Received by Manufacturer: 12/21/2016
• Supplement Date Received by Manufacturer: Not provided; 02/23/2017
• Initial Report FDA Received Date: 01/16/2017
• Supplement Report FDA Received Date: 03/20/2017; 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: Required Intervention
• Patient Age: 37 YR