Overdenture Gold/Plastic Coping 1000-67Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841307109143), received between Apr 1, 2022 and Sep 20, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Fracture” (3 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
- Fracture3
Patient problems
- Failure of Implant3
- Impaired Healing3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 20, 2022Fracture; Fracture
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, FRACTURE OF BONE WAS OBSERVED.
Patient problems: Failure of Implant; Impaired Healing
MAUDE report 15456584 ↗InjuryApr 1, 2022Fracture; Fracture
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PRODUCT FRACTURE WAS OBSERVED.
Patient problems: Failure of Implant; Impaired Healing
MAUDE report 13976917 ↗InjuryApr 1, 2022Fracture; Fracture
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PRODUCT FRACTURE WAS OBSERVED.
Patient problems: Failure of Implant; Impaired Healing
MAUDE report 13976852 ↗
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- 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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