MAUDE Adverse Event Report: ZIMMER BIOMET SPINE ARDIS PEEK IMPLANT 12X09X26; ARDIS INTERBODY SYSTEM

Catalog Number 3201-120926

Device Problem Crack (1135)

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

Event Date 12/09/2016

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported that a cage cracked during implantation while the surgeon was using a mallet to place the cage into the patient's disc space.The cage was removed from the patient and replaced with another cage of the same size without incident.There are no reports of patient injury associated with this event.

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Manufacturer Narrative

The returned spacer was evaluated.There were cracks around the inserter attachment point.However, the spacer remains fully intact.A review of the manufacturing records did not identify any issues which may have contributed to this event.The labeling was reviewed and found to contain instructions regarding the proper usage and installation of the device.The cause of the event is unknown.

• Brand Name: ARDIS PEEK IMPLANT 12X09X26
• Type of Device: ARDIS INTERBODY SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer Contact: geoffrey gannon ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 6234402
• MDR Text Key: 64217025
• Report Number: 3004485144-2017-00018
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: PK133184
• 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: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3201-120926
• Device Lot Number: 2314871
• Other Device ID Number: (01)00889024333796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2016
• Initial Date FDA Received: 01/09/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/10/2017; 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention