MAUDE Adverse Event Report: WARSAW ORTHOPEDICS PROSTHESIS, INTERVERTEBRAL DISC

Catalog Number 6474627

Device Problem Mechanical Problem (1384)

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

Event Date 05/17/2016

Event Type  malfunction  

Manufacturer Narrative

The product is not returned to manufacturer for evaluation therefore we cannot determine definitive cause of event.

Event Description

It was reported that patient with degenerative disc disease underwent unspecified spinal procedure.Intra-op, during the milling of end plates at c4-c5, the cutter stopped.Surgeon opened a new cutter to finish the procedure.No patient complications were reported.

Manufacturer Narrative

Product analysis: visual and optical examination of the mill gear and mill pinion interfacing features identified significant material wear.The location and nature of the wear is consistent with instrument usage; 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: 5716341
• MDR Text Key: 47163151
• Report Number: 1030489-2016-01751
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 06/30/2016

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: 06/12/2023
• Device Catalogue Number: 6474627
• Device Lot Number: EM14M001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2016
• Initial Date FDA Received: 06/10/2016
• Supplement Dates Manufacturer Received: Not provided; 06/30/2016
• Supplement Dates FDA Received: 07/04/2016; 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2015
• 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: 48 YR