Henry Schein 9007599Recalls & reported problems
Henry Schein, Inc. · Maxima Distal End Cutter · Class 1
- 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 00304040120293), received between Apr 17, 2026 and Apr 17, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 2026Material Fragmentation
A PIECE OF THE WORKING END OF THE DEVICE BROKE INSIDE THE PATIENT'S MOUTH DURING AN ORTHO PROCEDURE. THEY WERE SENT TO ER AND IMAGING FOUND THE PIECE IN THEIR INTESTINE. PATIENT WAS SCHEDULED FOR FOLLOW UP IN TWO WEEKS TO HAVE IT REMOVED. THE PIECE WAS LATER DISCHARGED FROM THE BODY AND NO SURGICAL INTERVENTION WAS REQUIRED.
Patient problems: Foreign Body In Patient
MAUDE report 24911651 ↗
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- Triumph® 205-202Ortho Organizers, Inc. · PLIER, ORTHODONTIC1 report
- Ormco Premium 866-2013Ormco Corporation · PLIER, ORTHODONTIC1 report
- HU-FRIEDY 678-702Hu-Friedy Mfg. CO., LLC · PLIER, ORTHODONTIC1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.