TITAN IMPLANTS, INC. BC-5S8SRecalls & reported problems
Titan Implant Inc · 5.0mm Diameter Implant Length 8.0mm Sandblast 3.0mm Well · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842448101501), received between Nov 7, 2019 and Nov 7, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (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
- Failure to Osseointegrate2
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 7, 2019Failure to Osseointegrate; Failure to Osseointegrate
DENTAL IMPLANT DID NOT OSSEOINTEGRATE. THE DENTIST SENT US A LUMP SUM OF DENTAL IMPLANTS AND LIST OF PATIENT NAMES; CLAIMING THE IMPLANTS DID NOT OSSEOINTEGRATE. WE PROVIDED HIM WITH IMPLANT FAILURE FORMS. IMPLANT FAILURE FORMS AND RADIOGRAPHS ARE MISSING.
Patient problems: Failure of Implant
MAUDE report 9293007 ↗InjuryNov 7, 2019Failure to Osseointegrate; Failure to Osseointegrate
DENTAL IMPLANT DID NOT OSSEOINTEGRATE. THE DENTIST SENT US A LUMP SUM OF DENTAL IMPLANTS AND LIST OF PATIENT NAMES; CLAIMING THE IMPLANTS DID NOT OSSEOINTEGRATE. WE PROVIDED HIM WITH IMPLANT FAILURE FORMS. IMPLANT FAILURE FORMS AND RADIOGRAPHS ARE MISSING.
Patient problems: Failure of Implant
MAUDE report 9292027 ↗
Other Implant, Endosseous, Root-Form devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 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.
How reports and recalls are matched · Editorial policy · Report an error on this page