MAUDE Adverse Event Report: ZIMMER SPINE ARDIS PEEK IMPLANT 11X09X26

Model Number 3201-110926

Device Problem Positioning Problem (3009)

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

Event Date 04/28/2015

Event Type  malfunction  

Event Description

It was reported that during surgery, the implants did not seat firmly to the inserter and would not stay attached to the inserter.

Manufacturer Narrative

It is indicated that the device will not be returned for evaluation.Review of all records for this device and 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: ARDIS PEEK IMPLANT 11X09X26
• Type of Device: ARDIS PEEK IMPLANT 11X09X26
• Manufacturer (Section D): ZIMMER SPINE; 7375 bush lake rd.; minneapolis MN 55439
• Manufacturer Contact: scott lapointe ; 7375 bush lake rd.; minneapolis, MN 55439 ; 9528325600
• MDR Report Key: 4777953
• MDR Text Key: 5779311
• Report Number: 2184052-2015-00045
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3201-110926
• Device Catalogue Number: 3201-110926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2015
• 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