Inion CPS™ Baby 1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06438408000133), received between Jan 8, 2026 and Jan 8, 2026 — classified as 1 injury.

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

3 other recalls cover devices cleared under the same FDA submission (K010351, K020266); 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.

• InjuryJan 8, 2026Crack

  DURING A SURGERY IN A HOSPITAL, THE USER HAD PROBLEMS WITH THE INION CPS BABY SCREWS (TWO SCREW SIZES, REFS REPORTED SEPARATELY). THERE WAS A 60-MINUTE DELAY IN A PATIENT'S CRANIAL OPERATION DUE TO SCREW PICKING PROBLEMS FROM THE SCREW RING (IT WAS REPORTED THAT THE SCREWS DID NOT STICK TO SCREWDRIVER AND SCREWS DROPPED FROM THE SCREWDRIVER AFTER PICKING) AND SCREW PLACEMENT PROBLEMS (SCREWS BROKE DURING INSERTION). BESIDES THE 60-MINUTE DELAY, NO OTHER PATIENT HARM WAS REPORTED. THE SURGERY WAS COMPLETED BY USING INION CPS BABY SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24002142 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K010351, K020266. One submission often covers many models, so check the product and lot details in each record.

• Z-0630-2011 · Apr 14, 2010 · Terminated
  1.5 mm Inion CPS Baby, 4 hole plate, REF PLT-1000, sterile, Manufacturer, INION Oy, Finland.
• Z-0631-2011 · Apr 14, 2010 · Terminated
  1.5 mm Inion CPS Baby , 20 hole plate, REF PLT-1001, sterile, Manufacturer, INION Oy, Finland.
• Z-1550-2010 · Mar 5, 2010 · Terminated
  Inion 1.5 x 6mm CPS(R) Baby Screw, 1.5mm Inion CPS(R) Baby 5+E, REF SCR 1221, 5/pack, STERILE/R Stryker Craniomaxillofacial, Portage, MI. The INION CPS BABY 1.5 BIOABSORBABLE FIXA