MAUDE Adverse Event Report: EXTREMITY MEDICAL, LLC. OMNI PLATING; BONE PLATE

Catalog Number	144-42112
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an omni mtp plate was removed due to patient pain.The mtp plate was attempted to be removed with post and no lag screw.All plate screws were removed first.When attempted to remove the post it spun in place.Surgeon pulled plate up hoping that post would come up with it but the post went through the plate hole and stayed in bone.Dr had to rongeur post and was only able to get half of it.

• Brand Name: OMNI PLATING
• Common Device Name: BONE PLATE
• Manufacturer (Section D): EXTREMITY MEDICAL, LLC.; 300 interpace parkway; building a, 2nd floor; parsippany NJ 07054
• Manufacturer Contact: mary hoffman ; 300 interpace parkway; building a, 2nd floor; parsippany, NJ 07504 ; 9735888980
• MDR Report Key: 23587283
• Report Number: 3007289093-2025-00013
• Device Sequence Number: 9641427
• Product Code: HRS
• UDI-Device Identifier: 00842078115282
• UDI-Public: (01)00842078115282
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K221362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 144-42112
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/18/2025
• 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