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

Model Number	MTPL-7
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Sales rep reported on (b)(6) 2026 that a surgeon reported a broken mtpl-7 found after performing post op x-rays (date of x-rays are unknown) but the original implant date was (b)(6) 2025.The surgeon plans to remove the hardware/ culture and see how the patient does however the revision case is not scheduled.After 6 follow-up attempts to collect information about the patient, potential causes and information from the surgeon, the rep stated he does not have a lot of information to provide but he knows the joint did not heal.As of (b)(6) 2026 trimed has not received any additional information regarding the status of when the removal surgery will take place.X-rays were provided but as of (b)(6) 2026 the device remains implanted.

• 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; santa clarita CA 91355
• Manufacturer (Section G): TRIMED, INC.; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer Contact: megan rissler ; 27533 avenue hopkins; santa clarita, CA 91355
• MDR Report Key: 24273708
• Report Number: 2031009-2026-00001
• Device Sequence Number: 10030609
• 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: 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): 02/05/2026

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
• Operator of Device: Health Professional
• Device Model Number: MTPL-7
• Device Catalogue Number: MTPL-7
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 02/05/2026
• 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