BioHorizons CRTSBRecalls & reported problems
Biohorizons Implant Systems, Inc · Conical Titanium Implant-level Scan Body, Regular · Class 1
Data updated Oct 13, 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 00847236025557), received between Oct 29, 2025 and Apr 30, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Misconnection” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Misconnection3
- Connection Problem1
- No Apparent Adverse Event1
- Use of Device Problem1
Patient problems
- Insufficient Information4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2026Misconnection; Connection Problem; No Apparent Adverse Event
THIS REPORT COVERS THIRTEEN (13) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED THE DEVICE(S) EXPERIENCING SEATING ISSUE/MISALIGNMENT. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25045084 ↗InjuryApr 6, 2026Misconnection
SCANBODY WILL NOT FULLY SEAT IN IMPLANTS.
Patient problems: Insufficient Information
MAUDE report 24790687 ↗InjuryApr 6, 2026Misconnection
SCANBODY WILL NOT FULLY SEAT IN IMPLANTS.
Patient problems: Insufficient Information
MAUDE report 24789955 ↗MalfunctionOct 29, 2025Use of Device Problem; Use of Device Problem
THIS REPORT INDICATES A SIGNLE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED OF THE DEVICE(S) WAS REPORTED FAULTY DURING OPERATION. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23413583 ↗
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- N/A 68015187Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous266 reports
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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.
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