1.5 mm Inion CPS®Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06438408000409), received between Mar 31, 2022 and Apr 21, 2023 — classified as 2 injuries.

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

3 other recalls cover devices cleared under the same FDA submission (K010352); 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.

• InjuryApr 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  INION PLT-1008 WAS USED IN THE LOWER EYE ORBITAL, AND EYELID ECTROPION OCCURED ABOUT TWO MONTHS LATER. REOPERATION WAS NEEDED.

  Patient problems: Eye Irritation

  MAUDE report 16783623 ↗
• InjuryMar 31, 2022Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  ONE YEAR AFTER LEFT ORBITAL INCISION AND ORBITAL TUMOR RESECTION A RE-OPERATION WAS CONDUCTED DUE TO LEFT EYELID FISTULA, WHEN CONSERVATIVE APPROACH HAD NOT WORKED SUCH AS CLEANING AND DISINFECTING THE AREA. IMPLANT REMNANTS WERE REMOVED. NO OBVIOUS ABSCESS CAVITY WAS FOUND AROUND THE BONE PLATE AND ORBITAL CAVITY. THE PATIENT'S CONDITION IS REPORTED GOOD.

  Patient problems: Fistula; Foreign Body Reaction

  MAUDE report 13963211 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K010352. One submission often covers many models, so check the product and lot details in each record.

• 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-0630-2011 · Apr 14, 2010 · Terminated
  1.5 mm Inion CPS Baby, 4 hole plate, REF PLT-1000, 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