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

Catalog Number	6470317
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Cyst(s) (1800)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent cervical disc arthroplasty at c5-6.Post-op, cysct was found on films posterior to the implant.As a result of this anterior cervical discectomy and fusion (acdf) had to be performed in which the surgeon pulled the implant out using a cochlear.The surgeon said he broke the anterior portion of the polyurethane sheath taking the implant out.The surgeon inspected the implant and noticed the posterior portion of the polyurethane sheath was damaged as well.He said he did not break the posterior portion of the polyurethane sheath.He believes that the posterior portion of the polyurethane sheath was broken prior to the revision surgery and with it being broken the particle wear caused the cyst.The implant was completed explanted.
Additional Manufacturer Narrative
Additional information: due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.Product analysis: there are multiple tears/rips in the anterior sheathing of the bryan discs.All of the tears/rips are non-uniform in appearance and do not appear to have been made by a surgical cutting device.The largest of the tears is ~15mm long and appears to have been made by two separate cuts that have intercepted each other.The other tears are ~3mm in length.All of the tears are off the center line of the implant.It would appear that tears may be the result of contract inside the patient.If information is provided in the future, a supplemental report will be issued.
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: 7365104
• Report Number: 1030489-2018-00443
• Device Sequence Number: 16487163
• Product Code: MJO
• UDI-Device Identifier: 00613994181237
• UDI-Public: 00613994181237
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P060023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 10/04/2018

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: 01/02/2019
• Device Catalogue Number: 6470317
• Device Lot Number: 0293584W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Initial Date Received by Manufacturer: 03/08/2018
• Supplement Date Received by Manufacturer: 07/03/2018; 08/08/2018
• Initial Report FDA Received Date: 03/23/2018
• Supplement Report FDA Received Date: 07/13/2018; 10/04/2018
• 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: 46 YR