MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 22X9X12 MM TM ARDIS INTERBODY SYSTEM SOLID

Catalog Number 06-702-01121

Device Problem Inaccurate Information (4051)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/17/2023

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 there was a discrepancy between the legal label (japanese) and the patient stickers included with the implants.The product was a 26mm cage that was labeled correctly when initially manufactured.However, the product was mislabeled as a 22mm cage during the over-labeling process within japan to add the legal label in japanese for sale there.The 26mm cage was implanted during surgery unintentionally, as the surgeon thought he was installing a 22mm cage.There have been no impacts to the patient to date.

• Brand Name: 22X9X12 MM TM ARDIS INTERBODY SYSTEM SOLID
• Type of Device: TM 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: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 16925973
• MDR Text Key: 315485802
• Report Number: 3012447612-2023-00157
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00889024397231
• UDI-Public: (01)00889024397231(17)240930(10)64423815
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06-702-01121
• Device Lot Number: 64584415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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