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 02/19/2015

Event Type  malfunction  

Manufacturer Narrative

Additional information: functional evaluation confirms pinion and gear interface slippage.Visual and optical examination of the -03 mill gear and -05 mill pinion interfacing features identified significant material plastic deformation.The location and nature of the wear is consistent with instrument usage; this instrument is a single-use instrument.Conclusion: the above observations are consistent with anticipated wear.

Event Description

It was reported that the patient underwent a cervical disc arthroplasty procedure.During the surgery while milling, it was found that the cephalad level end plate did not mill properly.The mill was pulled out to be tested and it was found that it was no longer spinning.Another mill had to be used to complete the surgery.No patient complications were reported.

Manufacturer Narrative

(b)(4): the device was not returned to the manufacturer for evaluation.

• 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): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4578366
• MDR Text Key: 19701488
• Report Number: 1030489-2015-00469
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2015

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: 03/17/2022
• Device Catalogue Number: 6474526
• Device Lot Number: EM13H038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2015
• Initial Date FDA Received: 03/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2014
• 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 Age: 00038 YR