MAUDE Adverse Event Report: ZIMMER SPINE ARDIS PEEK IMPLANT 09X09X22

Model Number 3201-090922

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that ardis cages could not have been attached to the holder.

Manufacturer Narrative

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 09X09X22
• Type of Device: ARDIS PEEK IMPLANT 09X09X22
• 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: scott lapointe ; 7375 bush lake road; minneapolis, MN 55439 ; 9528325600
• MDR Report Key: 4908247
• MDR Text Key: 6535033
• Report Number: 2184052-2015-00067
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K073202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 3201-090922
• Device Catalogue Number: 3201-090922
• Device Lot Number: 2436191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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