MAUDE Adverse Event Report: WARSAW ORTHOPEDICS PROSTHESIS, INTERVERTEBRAL DISC

Catalog Number 6474625

Device Problem Mechanical Problem (1384)

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

Event Date 11/08/2016

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

It was reported that on (b)(6) 2016, patient underwent discectomy and decompression following disc prosthesis placement at levels c6-c7.Intra-op, surgeon started to use the cutter, it started working normally but after a while it jammed and stopped working.Another cutter had to be used to finish the procedure.The product came in contact with the patient.No patient complications were reported.

Manufacturer Narrative

Product analysis: instrument unable to be disassembled without damage.Functional evaluation found operation of cutter operable, but with intermittent slippage 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.

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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6140428
• MDR Text Key: 61295967
• Report Number: 1030489-2016-03320
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 01/06/2017

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: 12/11/2023
• Device Catalogue Number: 6474625
• Device Lot Number: EM15G038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2016
• Initial Date FDA Received: 12/01/2016
• Supplement Dates Manufacturer Received: Not provided; 01/06/2017
• Supplement Dates FDA Received: 02/01/2017; 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2015
• 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: 38 YR