The Locking Pediatric Osteotomy Plate (LolliPOP) System POP-OB27-32Recalls & reported problems
Orthopediatrics Canada ULC · Polyaxial Compression Screw, Ø2.7 X 32mm · Class 2 · Implant
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 07540194005854), received between Oct 16, 2020 and Oct 16, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (1 report).
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
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 16, 2020Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth
A COMPRESSION SCREWS ATTACHING THE PLATE TO THE BONE BROKE BEING IMPLANTED IN AN INFANT PATIENT. INITIAL SURGERY: (B)(6) 2018 (B)(6)OF AGE). 2 YEARS AND 3 MONTHS IMPLANTATION BEFORE DETECTION OF FAILURE.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 10693246 ↗
Other APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT devices
- PRECICE® Plating System LP4.5-DLF31Nuvasive Specialized Orthopedics, Inc. · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component3 recalls0 reports
- R3 71364451Smith & Nephew, Inc. · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT145 reports
- DFS HA BONE SCREWS HAA60-15020Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 recalls0 reports
- DFS HA BONE SCREWS HAA60-11030Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 recalls0 reports
- DFS HA BONE SCREWS HAB60-12040Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 recalls0 reports
- DFS HA BONE SCREWS HAA60-13040Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 recalls0 reports
- DFS HA BONE SCREWS HAA60-18030Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 recalls0 reports
- DFS HA BONE SCREWS HAA60-15030Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 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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