PediLoc Locking Plate System 00-1050-3210Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841132109366), received between Aug 27, 2025 and Aug 27, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K083286); 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.

• MalfunctionAug 27, 2025Fracture; Fracture

  PLATE BROKE SOON AFTER PLACEMENT. PT WAS A 7 Y/O MALE 60KG, AND WAS NON-COMPLIANT WITH POST OP INSTRUCTIONS AND BEGAN WEIGHT BEARING TWO DAY POST-OP. PT STATED HE BENT OVER IN A SEATED POSITION AND FELT A POP. PT WAS FIXED WING TRANSPORTED TO OUR FACILITY AND THE HARDWARE WAS REMOVED AND REPLACED WITH TWO SS 3.5MM FLEX NAILS.

  Patient problems: Failure of Implant

  MAUDE report 22910080 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083286. One submission often covers many models, so check the product and lot details in each record.

• Z-2844-2016 · Jul 27, 2016 · Terminated
  3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fix
• Z-2843-2016 · Jul 27, 2016 · Terminated
  3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fix
• Z-1941-2013 · Jul 24, 2013 · Terminated
  3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw.
• Z-0432-2013 · Oct 18, 2012 · Terminated
  4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock
• Z-2057-2012 · Jun 14, 2012 · Terminated
  OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone