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

Catalog Number 6474525

Device Problem Mechanical Problem (1384)

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

Event Date 05/23/2017

Event Type  malfunction  

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.

Event Description

Patient demographics: gender: female it was reported that during surgery, the cutter malfunctioned.It was unknown whether the gears were sheared or if it was faulty to begin with.The product came in contact with the patient.No patient complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

Product analysis: instrument unable to be disassembled without damage.Functional evaluation found operation of cutter operable, but with intermittent slippage and jamming of internal gear and pinion, consistent with the -03 mill gear and -05 mill pinion interfacing features with significant material wear.This instrument is a single-use instrument.The above observations are consistent with anticipated wear.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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6649421
• MDR Text Key: 77832801
• Report Number: 1030489-2017-01576
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00613994363817
• UDI-Public: 00613994363817
• 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: 10/24/2017

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: 08/07/2023
• Device Catalogue Number: 6474525
• Device Lot Number: EM15F058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2017
• Initial Date FDA Received: 06/19/2017
• Supplement Dates Manufacturer Received: 05/23/2017; 09/29/2017
• Supplement Dates FDA Received: 10/05/2017; 10/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2015
• 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