MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. ARDIS PEEK IMPLANT 10X11X26; ARDIS INTERBODY SYSTEM

Catalog Number	3201-101126
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that during the implantation of the cage, the back edge of the cage broke off.The remaining cage was not removed per surgeon's discretion.There was no patient impact reported.
Additional Manufacturer Narrative
Additional information: methods, results, and conclusions - the device was not returned for evaluation.However a photo of the fractured piece was provided but it did not have enough detail with which to determine the cause of the fracture.A review of the manufacturing records did not identify any issues that would have contributed to this event.The device labeling was reviewed and found to contain instructions regarding proper device installation, including maintaining on-axis alignment between the implant and inserter.
Event or Problem Description
It was reported that during the implantation of the cage, the back edge of the cage broke off.The remaining cage was not removed per surgeon's discretion.There was no patient impact reported.

• Brand Name: ARDIS PEEK IMPLANT 10X11X26
• Common Device Name: ARDIS INTERBODY SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 8940477
• Report Number: 3012447612-2019-00355
• Device Sequence Number: 11300407
• Product Code: MAX
• UDI-Device Identifier: 00889024333697
• UDI-Public: (01)00889024333697(17)201130(10)63204698
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K133184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 3201-101126
• Device Lot Number: 63204698
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1