FDA Adverse Event
Malfunction
Summary report: N
OMNI PLATING
MDR report key: 23587283
·
Received November 18, 2025
Report
- Report Number
- 3007289093-2025-00013
- Event Type
- Malfunction
- Date Received
- November 18, 2025
- Date of Event
- October 22, 2025
- Report Date
- November 18, 2025
- Manufacturer
- EXTREMITY MEDICAL, LLC.
- Product Code
- HRS
- UDI-DI
- 00842078115282
- PMA / PMN Number
- K221362
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2363086 | OMNI PLATING | BONE PLATE | HRS | EXTREMITY MEDICAL, LLC. | 00842078115282 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |