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 01/23/2015

Event Type  malfunction  

Event Description

It was reported that the patient underwent surgery for cervical disc replacement.During the milling process, the instrument stopped spinning.No patient complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: 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.

• 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: 4524810
• MDR Text Key: 5491527
• Report Number: 1030489-2015-00332
• 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: 01/23/2015

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: 08/11/2022
• Device Catalogue Number: 6474526
• Device Lot Number: EM14G009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2015
• Initial Date FDA Received: 02/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2014
• 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: 00034 YR