2.0 mm Inion CPS® Baby 1Recalls & reported problems
Inion Oy · 2.0 x 7 mm screw · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06438408001185), received between Mar 24, 2021 and Mar 24, 2021 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bacterial Infection1
- Cellulitis1
- Foreign Body Reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RIGHT INTRAORBITAL TUMOR RESECTION FOR (B)(6) YEAR OLD FEMALE PATIENT WAS OPERATED. REDNESS AND SWELLING DEVELOPED 6 DAYS AFTER THE OPERATION. THERE WAS NO SIGNIFICANT IMPROVEMENT AFTER INTRAVENOUS INFUSION OF CEFTRIAXONE SODIUM, SO "ORBIT SIDEWISE OPENING OF THE RIGHT EYE, INTRAORBITAL ABSCESS INCISION AND DRAINAGE, ORBITAL SEPTUM REPAIR, EYELID SUTURE" WERE CARRIED OUT 3 WEEKS POST OPERATIVELY. 4 MONTHS AFTER THE INITIAL OPERATION,THE SKIN OF THE RIGHT ORBIT WAS ULCERATED. THE DIAGNOSIS WAS "RIGHT ORBIT CELLULITIS INFLAMMATION". AND REVISION SURGERY WAS PERFORMED. AT IMPLANT REMOVAL GRANULATION-LIKE TISSUE HYPERPLASIA WAS SEEN AND REMOVED, THE SOFT TISSUE NEAR THE ABSORBABLE PLATE WAS ERODED AND BRITTLE. THERE WAS NO OBVIOUS INFECTION IN THE EXPLORATION, AND THE OUTER ORBITAL BONE WAS HEALED WELL.
Patient problems: Bacterial Infection; Cellulitis; Foreign Body Reaction
MAUDE report 11559134 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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