Custom Legacy Titanium Abutment 8045-31-XXRecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10841307116851), received between Apr 18, 2018 and Feb 25, 2023 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Defective Component” (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
- Defective Component2
- Component or Accessory Incompatibility1
- Positioning Problem1
Patient problems
- Failure of Implant4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 25, 2023Component or Accessory Incompatibility; Component or Accessory Incompatibility
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PRODUCT FIT ISSUE WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 16440937 ↗MalfunctionSep 29, 2020Defective Component; Defective Component
PER (B)(4), BEFORE CLINICAL PROCEDURE, PRODUCT DEFORMITY WAS NOTICED.
Patient problems: Failure of Implant
MAUDE report 10600222 ↗MalfunctionSep 29, 2020Defective Component; Defective Component
PER (B)(4), BEFORE CLINICAL PROCEDURE, PRODUCT DEFORMITY WAS NOTICED.
Patient problems: Failure of Implant
MAUDE report 10600213 ↗InjuryApr 18, 2018Positioning Problem; Positioning Problem
DOCTOR CLAIMS THAT THE ABUTMENT IS TOO WIDE AND HE WAS UNABLE TO SEAT IT COMFORTABLY ON THE PATIENT DUE TO IT PINCHING THE PAPILLA. HE IS REQUESTING THAT WE REMAKE THE ABUTMENT. PROCEDURE REQUIRED SECOND SURGERY TO COMPLETE. THIS IS A REPORTABLE SERIOUS INJURY.
Patient problems: Failure of Implant
MAUDE report 7441857 ↗
Other Abutment, Implant, Dental, Endosseous devices
- CERTAIN® GOLD-TITE® IUNIHGZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS151 reports
- Nobel Biocare® 36662Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 recalls5 reports
- CERTAIN® IUNIHTZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS67 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS66 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · Abutment, implant, dental, endosseous54 reports
- Esthetic Abutment 36669Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall2 reports
- CERTAIN® BELLATEK® IEDAT5ZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall1 report
- Custom Abutments Final AbutmentsInstitut Straumann AG · Abutment, implant, dental, endosseous1 recall0 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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