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ACE 04948001Recalls & reported problems

Ace Surgical Supply CO., Inc. · BUR TREPHINE 35TL 2ID 2.8OD TI 18.5CL CA MRKS 8-10-13-15-18 INTERNAL IRRIGATION · 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 00614950011797), received between Feb 24, 2020 and Feb 24, 2020 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 24, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    PER ASSISTANT AT THE OFFICE, SHE SAID THAT THEY WERE PERFORMING AN IMPLANT REMOVAL PROCEDURE WHEN THE PRODUCT BROKE IN HALF INSIDE A PATIENT'S MOUTH. THE PATIENT WAS NOT INJURED AND THE PIECE WAS REMOVED.

    Patient problems: No Code Available

    MAUDE report 9743856 ↗

Other TREPHINE devices

All TREPHINE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.