MAUDE Adverse Event Report: ZIMMER SPINE VIRAGE CLOSURE TOP

Model Number 07.01728.001

Device Problem Malposition of Device (2616)

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

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon further evaluation of event details.

Event Description

It was reported that a closure top backed out postoperatively.Additional information has been requested but has not been received at this time.

Manufacturer Narrative

It is indicated that the device will not be returned for evaluation; therefore, analysis of device records could not be performed as the lot number is unknown.Review of all provided information concluded that there is no evidence of a product defect or deficiency.This is the final report that will be submitted associated with this incident and device.No additional action is required at this time.

• Brand Name: VIRAGE CLOSURE TOP
• Type of Device: VIRAGE CLOSURE TOP
• Manufacturer (Section D): ZIMMER SPINE; 7375 bush lake road; minneapolis MN 55439
• Manufacturer (Section G): ZIMMER SPINE; 7375 bush lake road; minneapolis MN 55439
• Manufacturer Contact: rikke hanson ; 7375 bush lake road; minneapolis, MN 55439 ; 9528325600
• MDR Report Key: 5330140
• MDR Text Key: 35024125
• Report Number: 2184052-2015-00152
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2015

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 Model Number: 07.01728.001
• Device Catalogue Number: 07.01728.001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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