MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PEEK IMPLANT 10X09X26; ARDIS INTERBODY SYSTEM

Catalog Number 3201-100926

Device Problem Crack (1135)

Patient Problem No Code Available (3191)

Event Date 04/11/2018

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 spacer cracked by the area where the inserter attaches to the spacer while being installed into the disc space.There was a surgical delay greater than 30 minutes in duration associated with implant positioning.The spacer remains implanted.There were no reported patient impacts associated with the delay or the cracked spacer.

Manufacturer Narrative

The implant was not returned for evaluation, so no results are available and no conclusions can be drawn.A review of the dhr did not reveal any manufacturing related issues which would have contributed to this event.

• Brand Name: PEEK IMPLANT 10X09X26
• 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: 7530858
• MDR Text Key: 108844909
• Report Number: 3012447612-2018-00428
• 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: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3201-100926
• Device Lot Number: 63331365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR