MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO MTP PLT,CONTRD,STD,R,TI; BONE FIXATION PLATE

Model Number	LO-PRO MTP PLT,CONTRD,STD,R,TI
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that 8 weeks after a surgery where a mtp plate was implanted, the patient has developed a skin reaction.The surgery date was (b)(6) 2025.The plate remains implanted.No further information received.

• Brand Name: LO-PRO MTP PLT,CONTRD,STD,R,TI
• Common Device Name: BONE FIXATION PLATE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 24270212
• Report Number: 1220246-2026-00436
• Device Sequence Number: 10723186
• Product Code: HRS
• UDI-Device Identifier: 00888867053007
• UDI-Public: 00888867053007
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K150456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: LO-PRO MTP PLT,CONTRD,STD,R,TI
• Device Catalogue Number: AR-8944CR-S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• 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: Other
• Patient Sex: Unknown