MECTRON OT7S-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI E322033700140), received between Feb 14, 2017 and Feb 14, 2017 — 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

Recent adverse event reports

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

• InjuryFeb 14, 2017Break

  DOCTOR WAS PERFORMING AN ALVEOLAR RIDGE SPLIT. DOCTOR BROKE THE INSERT TIP IN PATIENT BONE. DOCTOR PLACED DENTAL IMPLANT. DOCTOR TOOK DENTAL X-RAYS AND OBSERVED BROKEN INSERT TIP IN BON IN X-RAY. DOCTOR REMOVED IMPLANT AND ATTEMPTED TO RETRIEVE BROKEN INSERT TIP. DOCTOR WAS UNABLE TO RETRIEVE INSERT TIP. DOCTOR REPLACED DENTAL IMPLANT. DOCTOR CONTACTED PIEZOSURGERY INCORPORATED FOR ADVICE ON HOW TO PROCEED. DOCTOR WAS ADVISED TO REMOVE THE BROKEN INSERT TIP. DOCTOR STATED THAT BECAUSE THE INSERT TIP IS COMPOSED OF SIMILAR MATERIAL TO THAT OF SURGICAL STEEL AND TITANIUM IN WIRES AND OTHER DENTAL HARDWARE THAT IS MADE TO REMAIN IN THE BODY, THAT HE WOULD LEAVE THE INSERT TIP IN THE BONE OF THE PATIENT AND MONITOR THE PATIENT. PIEZOSURGERY INCORPORATED INDICATED THAT THE DEVICE MANUAL EXPLICITLY STATES TO REMOVE INSERT FRAGMENTS. DOCTOR STATED THAT TO REMOVE THE TIP INSERT, HE WOULD HAVE TO ABORT HIS PROCEDURE. PIEZOSURGERY INCORPORATED ADVISED THE DOCTOR TO ABORT THE PROCEDURE. PIEZOSURGERY INCORPORATED STATED THAT IT WOULD REPORT THE EVENT AND SENT THE DOCTOR RMA PAPERWORK AND ADVERSE EVENT FORMS TO FILL OUT. DOCTOR FAILED TO RETURN EMAIL, PHONE CALLS, AND CERTIFIED MAIL CORRESPONDE

  Patient problems: Foreign Body In Patient

  MAUDE report 6330142 ↗