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

Catalog Number 6470317

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Inadequate Pain Relief (2388); Neck Pain (2433)

Event Type  Injury  

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 Description

It was reported that on (b)(6) 2014, the patient underwent surgery at levels c6-c7; c4-c5 with implantation of artificial cervical disc at level c6-c7 due to pre-op diagnosis: neck pain, disc herniation.On (b)(6) 2014, the patient underwent anterior cervical disc fusion(acdf) surgery at levels c4-c5,c5-c6,c6-c7 with implantation of another artificial cervical disc.On (b)(6) 2017, the patient underwent a revision surgery in which both the discs implanted were removed.The surgeon stated that the patient had a brief period of neck pain relief but that the neck pain has continued and the patient was also experiencing occipital headaches.Disc were being removed due to persistent neck pain.Removal of both discs were uncomplicated but surgeon noted some heterotopic ossification (grade posterolateral to artificial disc replacement device."ho" was removed with drill.The artificial disc replacement device plus peri-prosthetic tissue was sent for analysis per fda requirements.Revision treatment included three level using peek plus anterior plate.Tissue ingrowth was observed between superior and inferior device components.Metal debris was visible in tissue lateral to lp device.The current status of patient is unknown but patient did recover from revision surgery.

• Brand Name: BRYAN CERVICAL DISC SYSTEM
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6309843
• MDR Text Key: 66760396
• Report Number: 1030489-2017-00261
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00613994181237
• UDI-Public: 00613994181237
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2018
• Device Catalogue Number: 6470317
• Device Lot Number: 0275102W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2017
• Initial Date FDA Received: 02/07/2017
• Supplement Dates Manufacturer Received: 01/13/2017
• Supplement Dates FDA Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 109