PediNail Intramedullary Platform 00-1502-0732Recalls & reported problems
Orthopediatrics Corp. · 7MM X 320MM CHILD NAIL, RIGHT · Class 2 · Implant
All models of PediNail Intramedullary Platform (11)
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 00841132146255), received between Feb 21, 2025 and Feb 21, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K172583); 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.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2025Material Twisted/Bent; Material Twisted/Bent
PROXIMAL ASPECT OF NAIL WARPED DURING INSERTION, CAUSING THE TARGETED TO BE INACCURATE WHEN ATTEMPTING PROXIMAL INTERLOCKING SCREWS. THIS CAUSED A DELAY OF GREATER THAN 30 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21433732 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K172583. One submission often covers many models, so check the product and lot details in each record.
- Z-0218-2020 · Aug 19, 2019 · TerminatedModel No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedull
- Z-0125-2020 · Aug 19, 2019 · TerminatedOrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used to attach the tar
- Z-0219-2020 · Aug 19, 2019 · TerminatedModel No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intra
Other ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES devices
- NA 03.033.001Synthes GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES265 reports
- GAMMA 3125-1180SStryker GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES249 reports
- NA 03.037.026Synthes GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES225 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls2 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-045Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- PRECICE® Intramedullary Limb Lengthening System LSC5-050Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- TRIGEN 71674067Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
- PRECICE Intramedullary Limb Lengthening System LSB5-040Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 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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