Distal Radius Plate, Dorsal (R), 9 Holes FRP 432Recalls & reported problems
Flower Orthopedics Corporation · Compatible with 2.7mm/3.5mm screws, implants for orthopedic bone fixation · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840118103923), received between Aug 26, 2020 and Aug 26, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K123562); 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
- Break1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2020Break; Break
COMPANY BECAME AWARE OF A DEVICE MALFUNCTION OF A CASE THAT OCCURRED IN 2016 ON (B)(6) 2020. THE SURGEON UTILIZED A DISTAL RADIUS PLATE, DORSAL (R), 9 HOLES TO FIX A FRACTURED DISTAL RADIUS. A COUPLE WEEKS AFTER SURGERY, THE PATIENT CAME BACK TO THE DOCTOR'S OFFICE, WITH PAIN, TO DISCOVER HE HAD REFRACTURED HIS WRIST AND THE PLATE HAD BROKEN IN HALF AT ONE OF THE MIDSHALF SCREW HOLES. THE SURGEON OPERATED AGAIN TO FIX THE BROKEN WRIST. HE REMOVED THE BROKEN HARDWARE AND USED A SIMILAR PLATE FROM ANOTHER COMPANY TO DO THE REVISION. THE PATIENT HAD NO FURTHER ISSUES.
Patient problems: Pain
MAUDE report 10454039 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K123562. One submission often covers many models, so check the product and lot details in each record.
- Z-0034-2022 · Sep 3, 2021 · TerminatedFlower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
- Z-1314-2015 · Feb 16, 2015 · TerminatedVariable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm
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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