Skip to content

Diatech Diamond Instruments 210857DDRecalls & reported problems

Coltène/Whaledent AG · 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 J006210857DD0), received between Aug 8, 2022 and Aug 8, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • InjuryAug 8, 2022Break; Break

    AN ISSUE WITH A DENTAL BURR THAT OCCURRED IN THE DENTAL CLINIC AT (B)(6) HOSPITAL. A FLAME-D862-012-8.0/ML WAS USED IN A PROCEDURE, AND A TIP BROKE OFF AND WAS SWALLOWED. NO REPORTED INJURY BUT THE PATIENT WAS HOSPITALIZED. PATIENT WAS SUBSEQUENTLY DISCHARGED WITH NO OTHER KNOWN NEGATIVE IMPACT AT THIS TIME. HOSPITAL WROTE AT (B)(6) 2022: "UNFORTUNATELY, WE ARE UNABLE TO PROVIDE ADDITIONAL INFORMATION AT THIS TIME."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15184319 ↗

Other Instrument, Diamond, Dental devices

All Instrument, Diamond, Dental devices →

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