MECTRON MT1520+Recalls & reported problems
Mectron SPA · Insert MT1520+ is an osteotomy surgical insert to be used in conjuction with Mectron Piezosurgery hanpieces · Class 2
Data updated Oct 16, 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 E322036000210), received between May 18, 2026 and May 18, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Nerve Damage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2026Insufficient Device Problem Information
ON FRIDAY MAY 1ST, 2026, MECTRON S.P.A.WAS INFORMED BY THE IMPORTER MECTRON NORTH AMERICA OF AN INCIDENT, WHICH OCCURRED DURING A SURGICAL PROCEDURE AT VIRGINIA MASON MEDICAL CENTER AND THAT MIGHT HAVE INVOLVED ONE OF ITS DEVICE. NO COMPANY PERSONNEL WAS PRESENT AT THE TIME. THE END USER FACILITY REPORTED A CASE OF NERVE AVULSION AND POSSIBLE DUROTOMIES DURING AN UNSPECIFIED PROCEDURE; HANDPIECE OVERHEATING DURING THE SURGERY WAS ALSO REPORTED, THOUGH IT IS UNCLEAR WHETHER OVERHEATING AND THE SURGICAL COMPLICATIONS OCCURRED AT THE SAME TIME. LOTS, SERIALS OF THE INVOLVED DEVICES, PATIENT INFORMATION AND DETAILS ON THE CLINICAL SEQUELAE OF THE ADVERSE EVENT WERE NOT REPORTED, IN SPITE OF REPEATED EFFORTS BY THE IMPORTER TO RETRIEVE SUCH INFORMATION.
Patient problems: Nerve Damage
MAUDE report 25198978 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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