Ti-Max X X-SG93LRecalls & reported problems
Nakanishi Inc. · Class 2
Data updated Oct 18, 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 04560264517905), received between Aug 5, 2025 and Aug 5, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
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 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ON JULY 10, 2025, NAKANISHI RECEIVED AN EMAIL FROM A DISTRIBUTOR ABOUT A PATIENT'S ACCIDENTAL INGESTION OF A DENTAL BUR. THE DETAILS NAKANISHI OBTAINED ARE AS FOLLOWS: A DENTIST WAS PERFORMING A GUIDED BONE REGENERATION PROCEDURE ON A PATIENT USING THE X-SG93L HANDPIECE (SERIAL NO. (B)(6). DURING THE PROCEDURE, THE BUR CAME OUT OF THE HANDPIECE, AND THE PATIENT SWALLOWED THE BUR. THE PATIENT WAS REPORTED TO BE FINE WITHOUT NEED FOR ADDITIONAL MEDICAL TREATMENT. ACCORDING TO THE DENTIST, THE BUR WAS TOO HARD TO BE INSTALLED TO THE DEVICE PRIOR TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22711604 ↗
Other HANDPIECE, ROTARY BONE CUTTING devices
- OsteoMed 450-0241Osteomed LLC · HANDPIECE, ROTARY BONE CUTTING9 reports
- Surgical Straight Handpiece SGS-E2SNakanishi Inc. · Handpiece, Rotary Bone Cutting8 reports
- OsteoMed 450-0034Osteomed LLC · HANDPIECE, ROTARY BONE CUTTING6 reports
- S-12 surgical handpiece 1:2 30061000W & H Dentalwerk Bürmoos GmbH · Handpiece, Rotary Bone Cutting3 reports
- OsteoMed 450-0390Osteomed LLC · HANDPIECE, ROTARY BONE CUTTING3 reports
- OsteoMed 450-0084Osteomed LLC · HANDPIECE, ROTARY BONE CUTTING3 reports
- OsteoMed 450-0021-00Osteomed LLC · HANDPIECE, ROTARY BONE CUTTING3 reports
- S-11 surgical handpiece 1:1 30056000W & H Dentalwerk Bürmoos GmbH · Handpiece, Rotary Bone Cutting2 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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