Guided Surgery Handle Insert 3.4mmD GS-3.4Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10841307122609), received between May 7, 2018 and Jun 12, 2023 — classified as 5 injuries.
The most frequently reported specific device problem is “Component or Accessory Incompatibility” (2 reports).
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.
Most reported problems
Device problems
- Component or Accessory Incompatibility2
- Separation Failure2
- Device-Device Incompatibility1
Patient problems
- Failure of Implant4
- Insufficient Information2
- No Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2023Separation Failure; Separation Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, COMPONENTS COULD NOT BE SEPARATED.
Patient problems: Failure of Implant
MAUDE report 17105661 ↗InjuryApr 19, 2023Component or Accessory Incompatibility; Component or Accessory Incompatibility
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, COMPONENTS COULD NOT BE SEPERATED.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 16767728 ↗InjuryApr 8, 2023Separation Failure; Separation Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, COMPONENTS COULD NOT BE SEPARATED.
Patient problems: Insufficient Information
MAUDE report 16704950 ↗InjuryMar 24, 2023Component or Accessory Incompatibility; Component or Accessory Incompatibility
PER COMPLAINT (B)(4) DURING CLINICAL PROCEDURE, COMPONENTS COULD NOT BE SEPARATED.
Patient problems: Failure of Implant
MAUDE report 16612347 ↗InjuryMay 7, 2018Device-Device Incompatibility; Device-Device Incompatibility
WHILE DOING GUIDED SURGERY THE DOCTOR FOUND THE DRILLS WOULDN'T MOVE THROUGH THE INSERTS PAST WERE THE NARROW APEX MEETS THE WIDER PART OF DRILL. BECAUSE DOCTOR HAD TO SKIP DRILL IN THE SEQUENCE THEY COULDN'T GET THE CORRECT SIZE OSTEOTOMY AND THE IMPLANT COULDN'T ACHIEVE STABILITY. THIS IS A REPORTABLE SERIOUS INJURY AND DEVICE MALFUNCTION, REQUIRING SECOND SURGERY TO COMPLETE THE PROCEDURE.
Patient problems: Failure of Implant; No Information
MAUDE report 7493157 ↗
Other Accessories, Implant, Dental, Endosseous devices
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- N/A 68015193Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous283 reports
- N/A 68015187Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous266 reports
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- NobelReplace® 37045Nobel Biocare AB · Accessories, implant, dental, endosseous2 recalls0 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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