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

Catalog Number	6474525
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional 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
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 6649421
• Report Number: 1030489-2017-01576
• Device Sequence Number: 13740540
• Product Code: MJO
• UDI-Device Identifier: 00613994363817
• UDI-Public: 00613994363817
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P060023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: 05/23/2017; 09/29/2017
• Initial Report FDA Received Date: 06/19/2017
• Supplement Report FDA Received Date: 10/05/2017; 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1