PediNail Intramedullary PlatformRecalls & reported problems across all models
Orthopediatrics Corp. · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 11 models of PediNail Intramedullary Platform by Orthopediatrics Corp. in the FDA's device registry (GUDID). Together they are named in 11 adverse event reports in the FDA's MAUDE database, received between Oct 2, 2024 and Apr 2, 2026 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Fracture” (8 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
PediNail Intramedullary Platform recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 19, 2019Terminated
Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures
Z-0125-2020 · Root cause: Device Design · Recall details · FDA record ↗
Most reported PediNail Intramedullary Platform problems
Device problems
- Fracture8
- Material Twisted/Bent3
Patient problems
- Failure of Implant8
- No Clinical Signs, Symptoms or Conditions3
PediNail Intramedullary Platform models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PediNail Intramedullary Platform 01-1503-0032ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 recall0 reports
- PediNail Intramedullary Platform 00-1504-0938ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- PediNail Intramedullary Platform 00-1501-0722ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- PediNail Intramedullary Platform 00-1502-0732ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- PediNail Intramedullary Platform 00-1503-0934ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- PediNail Intramedullary Platform 00-1504-0934ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- PediNail Intramedullary Platform 00-1504-0936ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- PediNail Intramedullary Platform 00-1503-1032ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- PediNail Intramedullary Platform 00-1504-1030ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- PediNail Intramedullary Platform 00-1504-1138ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- 1 report
Recent PediNail Intramedullary Platform adverse event reports
The 11 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2026Fracture
THE PATIENT EXPERIENCED SIGNIFICANT PAIN IN THE RIGHT FEMUR. DIAGNOSTIC XRAY IMAGING REVEALED A FRACTURE OF THE IMPLANTED INTRAMEDULLARY NAIL LOCATED IN THE RIGHT FEMUR. THE DEVICE HAD BEEN IMPLANTED IN THE SUMMER OF 2023.
Patient problems: Failure of Implant
MAUDE report 24767542 ↗MalfunctionMar 4, 2026Material Twisted/Bent
THE NAIL IN THE PATIENT'S FEMUR HAS BENT AT THE PROXIMAL THIRD AT THE SITE OF THE OSTEOTOMY.
Patient problems: Failure of Implant
MAUDE report 24504995 ↗MalfunctionJan 30, 2026Fracture
REAMER TIP BROKE OFF OF THE REAMER SHAFT INSIDE OF THE TIBIAL CANAL. UNABLE TO COMPLETE SURGERY, TEMPORARY EX FIX PUT ON, REVISION SURGERY THE NEXT DAY USING A SMITH AND NEPHEW TRIGEN NAIL.
Patient problems: Failure of Implant
MAUDE report 24224034 ↗MalfunctionSep 17, 2025Fracture; Fracture
DR. (B)(6) FROM (B)(6) REPORTED A POST-OPERATIVE ISSUE INVOLVING A 10-YEAR-OLD MALE PATIENT IMPLANTED WITH A 9MM X 360MM ADOLESCENT RIGHT NAIL (PART NO. 00-1504-0936). DURING A CLINIC VISIT, THE NAIL WAS FOUND BROKEN THROUGH THE MOST PROXIMAL SCREW HOLE OF THE DISTAL PORTION. A REVISION PROCEDURE WAS PERFORMED, AND THE DEVICE WAS REMOVED ON (B)(6) 2025. THE HOSPITAL DISPOSED OF THE BROKEN DEVICE, AND IT IS NOT AVAILABLE FOR EVALUATION. NO PATIENT INJURY OR DEATH WAS REPORTED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Failure of Implant
MAUDE report 23077457 ↗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 ↗MalfunctionJul 6, 2025Fracture; Fracture
9X380 RIGHT ADOLESCENT NAIL BROKE WHEN REMOVING. THIS CAUSED A DEALY OF GREATER THAN 30 MINS ON REMOVAL.
Patient problems: Failure of Implant
MAUDE report 22409182 ↗MalfunctionJun 25, 2025Fracture; Fracture
PATIENT HAS MCCUNE-ALBRIGHT SYNDROME WITH POLYOSTOTIC FIBROUS DYSPLASIA. PATHOLOGIC FRACTURE IN 2016 AND 2017 BOTH TREATED WITH SPICA CASTS. ON (B)(6) 2020PATIENT UNDERWENT OSTEOTOMIES OF HIS LEFT PROXIMAL AND DISTAL FEMUR AND A FD ROD WAS IMPLANTED. ON (B)(6) 2023 THE FD ROD WAS EXCHANGED FOR A PNP FEMORAL NAIL. ON (B)(6) 2024 THE RIGID NAIL WAS EXCHANGED DUE TO HARDWARE FAILURE SECONDARY TO BEING PUSHED DOWN AT SCHOOL. WAS DOING WELL ON (B)(6) 2025 BUT FELL WHILE IN CHINA AND RETURNED TO CLINIC 5-6-25 WHERE X-RAYS SHOWED THE RIGID NAIL HAD BROKEN THROUGH THE PROXIMAL TRANSVERSE SCREW HOLE.
Patient problems: Failure of Implant
MAUDE report 22328164 ↗MalfunctionMar 17, 2025Material Twisted/Bent; Material Twisted/Bent
9X340MM PNP NAIL WAS IMPLANTED, LOCKED DISTALLY AND THE SURGEON DE-ROTATED THE DISTAL FRAGMENT BELOW THE OSTEOTOMY. THE RESIDENT ATTEMPTED TO DRILL THE GREATER/LESSER PROXIMAL LOCKING HOLE BUT WAS UNABLE TO GET ALIGNMENT. AFTER SEVERAL TRIES, THE DECISION WAS TO REMOVE THE NAIL TO EXAMINE AND IT WAS DISCOVERED THAT AT THE CONNECTION OF THE TARGETING ARM AND NAIL WHERE THE ATTACHMENT BOLT CONNECT, THE NAIL HAD SPLAYED FROM FATIGUE/STRESS FROM DE-ROTATING AND THIS CAUSED THE INABILITY TO LINE UP THE TARGETING ARM WITH THE PROXIMAL LOCKING OPTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21621879 ↗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 ↗MalfunctionNov 4, 2024Fracture; Fracture
WHEN SURGEON WAS REMOVING PNP NAIL, VIA THE CONICAL EXTRACTOR AND EXTRACTOR, THE CONICAL EXTRACTOR BROKE OFF INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20605239 ↗MalfunctionOct 2, 2024Fracture; Fracture
NAIL WAS IMPLANTED IN SPAIN BY DOCTOR MORALEDA. BREAKAGE OF THE NAIL WAS DISCOVERED BY DR (B)(4) IN DUBAI AND PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2024.
Patient problems: Failure of Implant
MAUDE report 20356099 ↗
Other Orthopediatrics Corp. products
All Orthopediatrics Corp. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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