PediNail Intramedullary Platform 00-1504-0934Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841132146811), received between Sep 17, 2025 and Sep 17, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2025Fracture; Fracture

  DR. (B)(6) FROM THE (B)(6) REPORTED A POST-OPERATIVE ISSUE INVOLVING A 17-YEAR-OLD FEMALE PATIENT IMPLANTED WITH A 9X360 PNP ADOLESCENT RIGHT NAIL (PART NO. 00-1504-0935). DURING A CLINIC VISIT, THE PATIENT REPORTED FEMORAL PAIN NEAR THE INCISION SITE. IMAGING REVEALED A BROKEN NAIL AT THE TRANSVERSE SCREW HOLE. A REVISION PROCEDURE WAS PERFORMED, AND THE DEVICE WAS REMOVED ON (B)(6) 2025.

  Patient problems: Failure of Implant

  MAUDE report 23076858 ↗

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 · Terminated
  Model 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 · Terminated
  OrthoPediatrics 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 · Terminated
  Model 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