MAUDE Adverse Event Report: TRIMED, INC. 1ST MTP 0 DEGREE DORSIFLEXED,LT, 7-HOLE

Model Number	MTPL-7
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	05/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A sales rep reported on 02may2025 that upon x-ray review during a post-op appointment, the surgeon discovered a non-union after the mtpl-7 was implanted on (b)(6) 2024.It is unknown if the patient followed all post-op instructions and this was the first post op appointment where the issue was identified.A revision surgery is scheduled for (b)(6) 2025.Additional information was provided on 08may2025 that the hardware was removed successfully.The surgeon said the patient can be pain free after a removal like this so chose not to put any additional hardware in at this time even though the joint did not fuse.X-rays were provided and it is unknown if the device will be available to be returned.

• Brand Name: 1ST MTP 0 DEGREE DORSIFLEXED,LT, 7-HOLE
• Common Device Name: 1ST MTP 0 DEGREE DORSIFLEXED,LT, 7-HOLE
• Manufacturer (Section D): TRIMED, INC.; 27533 avenue hopkins; valencia CA 91355
• Manufacturer (Section G): TRIMED, INC.; 27533 avenue hopkins; valencia CA 91355
• Manufacturer Contact: megan rissler ; 27533 avenue hopkins; valencia, CA 91355
• MDR Report Key: 22079964
• Report Number: 2031009-2025-00011
• Device Sequence Number: 12937250
• Product Code: HRS
• UDI-Device Identifier: 00842188120022
• UDI-Public: 00842188120022
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K192696
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: MTPL-7
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown