MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PEEK IMPLANT 12X09X30; ARDIS INTERBODY SYSTEM

Catalog Number 3201-120930

Device Problem Crack (1135)

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

Event Date 07/19/2017

Event Type  malfunction  

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 the spacer cracked around the connection to the inserter while being installed into the disc space during surgery.The spacer was removed from the patient.There were no reports of patient injury associated with this event.

Manufacturer Narrative

The returned spacer was evaluated.A portion of the distal end has fractured off at the threads used to connect the spacer to the inserter.The cause is likely attributed to off-axis impaction forces placed on the device during installation.A review of the manufacturing records did not identify any issues which would have contributed to this event.

• Brand Name: PEEK IMPLANT 12X09X30
• Type of Device: ARDIS INTERBODY SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: geoffrey gannon ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 6793409
• MDR Text Key: 82666317
• Report Number: 3012447612-2017-00403
• 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
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 3201-120930
• Device Lot Number: 63331371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2016
• 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