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

Catalog Number 6474526

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).The device has not been returned to the manufacturer for evaluation.

Event Description

It was reported patient underwent surgery for stenosis.Intra-op, cutter did not turn.No patient complications were reported.

Manufacturer Narrative

Product analysis:functional evaluation of the returned instrument was able to turn cutter without sticking, jamming, and slipping.The instrument appears to be capable of performing its intended function.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 5534072
• MDR Text Key: 41536939
• Report Number: 1030489-2016-00839
• Device Sequence Number: 1
• Product Code: MJO
• 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,Followup
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2023
• Device Catalogue Number: 6474526
• Device Lot Number: EM15H031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2016
• Initial Date FDA Received: 03/30/2016
• Supplement Dates Manufacturer Received: Not provided; 04/18/2016
• Supplement Dates FDA Received: 05/16/2016; 09/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2015
• 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