Ti-Max X X-DSG20LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04560264528475), received between Aug 19, 2025 and Aug 19, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• InjuryAug 19, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  ON JULY 25, 2025, NAKANISHI RECEIVED A PHONE CALL FROM A DISTRIBUTOR ABOUT A MALFUNCTION OF A NSK HANDPIECE. THE DETAILS NAKANISHI OBTAINED ARE AS FOLLOWS. THE EVENT OCCURRED ON (B)(6), 2025. A DENTIST WAS PERFORMING AN IMPLANT PLACEMENT PROCEDURE ON A PATIENT USING THE X-DSG20L HANDPIECE (SERIAL NO. HEAD: (B)(6), SHANK: (B)(6)). THE PATIENT WAS UNDER LOCAL ANESTHESIA. DURING THE PROCEDURE, THE DENTIST FOUND A PIECE OF METAL ON THE PATIENT'S TONGUE AND REMOVED IT. THE DENTIST CHECKED THE HANDPIECE AND BUR BUT OBSERVED NO ABNORMALITIES AND CONTINUED WITH THE PROCEDURE. AFTER THE PROCEDURE, A CBCT SCAN WAS TAKEN TO CONFIRM THE IMPLANT POSITION, AND THE DENTIST DISCOVERED A PIECE OF METAL ON THE OUTER SIDE OF THE CORTICAL BONE OF THE LOWER JAW. ON THE SAME DAY AS THE INCIDENT, THE DENTIST REOPENED THE PATIENT'S INCISION, REMOVED THE PIECE OF METAL AND RE-SUTURED THE WOUND. ANOTHER CBCT SCAN WAS PERFORMED TO CONFIRM THAT THE METAL FRAGMENT HAD BEEN REMOVED. AFTER THE SURGERY, THE DENTIST RE-CHECKED THE HANDPIECE AND FOUND THAT THE INTERNAL PARTS OF THE HANDPIECE WERE REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22836809 ↗