PediatrOS™ RigidTack™ 30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048266138279), received between Aug 2, 2018 and May 4, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K151762); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2022Device Dislodged or Dislocated; Material Twisted/Bent

  THE PATIENT HAS BEEN IMPLANTED WITH RIGIDTACK STAPLES TO SLOW DOWN HIS GROWTH. TO TREAT A GENU VARUM THE STAPLES ON ONE SIDE OF THE LEG HAVE BEEN REMOVED. BY THAT THE STAPLES STARTED TO BEND AND DISLOCATE. HENCE THAT THE STAPLES HAVE BEEN REMOVED.

  Patient problems: Failure of Implant

  MAUDE report 14274409 ↗
• InjuryAug 2, 2018Device Dislodged or Dislocated; Material Deformation

  THE PATIENT HAS BEEN IMPLANTED WITH RIGIDTACK STAPLES TO SLOW DOWN HIS GROWTH. TO TREAT A GENU VARUM THE STAPLES ON ONE SIDE OF THE LEG HAVE BEEN REMOVED. BY THAT THE STAPLES STARTED TO BEND AND DISLOCATE. HENCE THAT THE STAPLES HAVE BEEN REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7742622 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151762. One submission often covers many models, so check the product and lot details in each record.

• Z-0650-2022 · Jan 18, 2022 · Terminated
  Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only