MAUDE Adverse Event Report: MEDARTIS INC. NEXTRA CH

Model Number	CH-35M, CH-M35M, CH-32P-KT
Medical Device Problem Codes	Use of Device Problem (1670); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We used nextra ch implant and the proximal and middle implants did not fit properly within each other.The implants were slipping out of each other every time he tried to close.Problem statement: implants would not lock.
Additional Manufacturer Narrative
If additional information is obtained which changes the outcome of the investigation, a follow up report will be filed.
Additional Manufacturer Narrative
The complaint is closed.There is no change to the outcome of the investigation.Additional fields were completed with known information not previously included.
Event or Problem Description
We used nextra ch implant and the proximal and middle implants did not fit properly within each other.The implants were slipping out of each other every time he tried to close.Problem statement: implants would not lock.

• Brand Name: NEXTRA CH
• Common Device Name: NEXTRA CH
• Manufacturer (Section D): MEDARTIS INC.; 1195; polk drive; warsaw IN 46582
• Manufacturer (Section G): MEDARTIS INC.; 1195; polk drive; warsaw IN 46582
• MDR Report Key: 21594660
• Report Number: 3009540749-2025-00001
• Device Sequence Number: 18362296
• Product Code: HWC
• UDI-Device Identifier: 00817701026310
• UDI-Public: 00817701026310
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K221610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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 Model Number: CH-35M, CH-M35M, CH-32P-KT
• Device Lot Number: 1574804, 1574809, 168101
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown