BioHorizons TP3DCRecalls & reported problems
Biohorizons Implant Systems, Inc · 3.0mm Direct Pickup Coping, Hexed · Class 1 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847236010638), received between Jul 31, 2025 and Oct 29, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (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.
Reports received per month
Most reported problems
Device problems
- Connection Problem1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THIS REPORT INDICATES A SINGLE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED OF THE DEVICE(S) HAS A EXPERIENCED A CONNECTION ISSUE. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23413464 ↗MalfunctionJul 31, 2025Connection Problem; Connection Problem
THIS REPORT SUMMARIZE ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENTS INVOLVED OF THE DEVICE(S) HAVING A CONNECTION ISSUE. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22682592 ↗
Other Accessories, Implant, Dental, Endosseous devices
- N/A 68015189Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous388 reports
- N/A 68015191Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous319 reports
- N/A 68015193Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous283 reports
- N/A 68015187Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous266 reports
- N/A 68015188Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous185 reports
- N/A 68015192Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous159 reports
- N/A 68015190Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous147 reports
- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page