BioHorizons PBTSBRecalls & reported problems
Biohorizons Implant Systems, Inc · 5.7mm Titanium Scan Body · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847236022518), received between Dec 2, 2025 and Jan 30, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- 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.
MalfunctionJan 30, 2026Insufficient Device Problem Information
THIS REPORT INDICATES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED THE DEVICE(S) EXPERIENCING A SEPARATION ISSUE. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 24226211 ↗InjuryDec 2, 2025Fracture; Fracture
THIS SCAN BODY GOT STUCK INSIDE AN IMPLANT (TIM7010; LOT: 2500220) AND COULD NOT BE REMOVED.
Patient problems: Insufficient Information
MAUDE report 23700008 ↗
Other Accessories, Implant, Dental, Endosseous devices
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- 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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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