MAUDE Adverse Event Report: WARSAW ORTHOPEDICS PROSTHESIS, INTERVERTEBRAL DISC

Catalog Number 6474627

Device Problems Mechanical Problem (1384); Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2018

Event Type  malfunction  

Manufacturer Narrative

Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.

Event Description

It was reported that the patient underwent cervical disc arthroplasty at c5/6 due to adjacent segment degeneration.Intra-op, when the surgeon used the cutter into the patient and depressed the foot-pedal, he heard a ¿snapping¿ sound when he was using the cutter and the cutter no longer worked.He removed the cutter and tested it ex-situ and noticed that it was no longer working.The product came in contact with the patient.There didn¿t seem to be any parts missing from the cutter.No any patient complications occurred during the event.

Manufacturer Narrative

Additional information: due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.Product analysis: 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.The above observations are consistent with wear.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: PROSTHESIS, INTERVERTEBRAL DISC
• 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: 7246918
• MDR Text Key: 99198952
• Report Number: 1030489-2018-00173
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P060023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6474627
• Device Lot Number: EM16E067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 45 YR