Propel ASM-20010-04Recalls & reported problems
Propel Orthodontics LLC · Assy. Packaged Perforation Device, Contra-Angle · Class 2
Data updated Oct 13, 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 00852673007028), received between Sep 14, 2021 and Sep 14, 2021 — 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.
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.
InjurySep 14, 2021Material Fragmentation
THE TIP OF THE PERFORATION SCREW (MOPS) BROKE IN THE SOFT TISSUE DURING A ORTHODONTIC PROCEDURE. THE PATIENT WAS REFERRED TO AN ORAL SURGEON WHERE THE FRAGMENT WAS SURGICALLY REMOVED AND BONE GRAFTING WAS PERFORMED TO PREVENT POSSIBLE TOOTH LOSS.
Patient problems: Foreign Body In Patient
MAUDE report 12466334 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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