ORTHO SOLUTIONS ULTOS PLATING SYSTEM OS292200Recalls & reported problems
Ortho Solutions Holdings Limited · K-WIRE TROCAR TIP 2.0MM X 150MM · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055662923124), received between Oct 1, 2020 and Oct 1, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K141784); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Fracture1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 1, 2020Fracture; Fracture
DURING AN ORIF PROCEDURE FOR A LEFT PROXIMAL HUMERUS FRACTURE, AS THE SURGEON WAS USING A K-WIRE TO STABILISE THE FRACTURE, PART OF THE WIRE BROKE, LEAVING A PORTION OF IT INSIDE OF THE PATIENT'S BONE. THE SURGICAL PROCEDURE WAS SUCCESSFUL, AND NO INJURY OR COMPLICATION FOR THE PATIENT WAS REPORTED. NO ADDITIONAL CLINICAL INFORMATION WAS PROVIDED, AND THE DEVICE WAS DISCARDED. THE K-WIRE IS MANUFACTURED FROM IMPLANT-GRADE 316LVM STAINLESS STEEL.
Patient problems: Foreign Body In Patient
MAUDE report 10611728 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K141784. One submission often covers many models, so check the product and lot details in each record.
- Z-0230-2026 · Sep 17, 2025 · Open, ClassifiedFuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS200120L, OS200125, OS200125L, OS200135, OS200324, OS200325, OS
- Z-0026-2016 · Jul 14, 2015 · TerminatedOrtho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Steril
Other Plate, Fixation, Bone devices
- Lapiplasty System 2 SK14Treace Medical Concepts, Inc. · Plate, Fixation, Bone260 reports
- PRECICE® Plating System LP4.5-PRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls6 reports
- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-MLT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-MRT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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