TITAN IMPLANTS, INC. BC-45S8SRecalls & reported problems
Titan Implant Inc · 4.5mm Diameter Length 8.0mm Sandblast 3.0mm Well · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Titan dental implant is placed in the jaw to replace a tooth root. The 24 reports describe the implant failing to bond with the bone, sometimes reported as implant failure. They include 24 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00842448101464), received between Nov 7, 2019 and Jan 9, 2020 — classified as 24 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (24 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 Osseointegrate24
Patient problems
- Failure of Implant21
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjuryJan 9, 2020Failure to Osseointegrate; Failure to Osseointegrate
DENTAL IMPLANT DID NOT OSSEOINTEGRATE. IMPLANT FAILURE FORMS WERE NOT FILLED IN COMPLETELY. RADIOGRAPHS ARE MISSING. REPEATED ATTEMPTS TO OBTAIN WERE MADE.
Patient problems: Failure of Implant
MAUDE report 9572502 ↗InjuryJan 9, 2020Failure to Osseointegrate; Failure to Osseointegrate
DENTAL IMPLANT DID NOT OSSEOINTEGRATE. IMPLANT FAILURE FORMS WERE NOT FILLED IN COMPLETELY. RADIOGRAPHS ARE MISSING. REPEATED ATTEMPTS TO OBTAIN WERE MADE.
Patient problems: Failure of Implant
MAUDE report 9572501 ↗InjuryJan 9, 2020Failure to Osseointegrate; Failure to Osseointegrate
DENTAL IMPLANT DID NOT OSSEOINTEGRATE. IMPLANT FAILURE FORMS WERE NOT FILLED IN COMPLETELY. RADIOGRAPHS ARE MISSING. REPEATED ATTEMPTS TO OBTAIN WERE MADE.
Patient problems: Failure of Implant
MAUDE report 9572500 ↗InjuryJan 9, 2020Failure to Osseointegrate; Failure to Osseointegrate
DENTAL IMPLANT DID NOT OSSEOINTEGRATE. IMPLANT FAILURE FORMS WERE NOT FILLED IN COMPLETELY. RADIOGRAPHS ARE MISSING. REPEATED ATTEMPTS TO OBTAIN WERE MADE.
Patient problems: Failure of Implant
MAUDE report 9572497 ↗InjuryJan 9, 2020Failure to Osseointegrate; Failure to Osseointegrate
DENTAL IMPLANT DID NOT OSSEOINTEGRATE. IMPLANT FAILURE FORMS WERE NOT FILLED IN COMPLETELY. RADIOGRAPHS ARE MISSING. REPEATED ATTEMPTS TO OBTAIN WERE MADE.
Patient problems: Failure of Implant
MAUDE report 9572495 ↗InjuryJan 9, 2020Failure to Osseointegrate; Failure to Osseointegrate
DENTAL IMPLANT DID NOT OSSEOINTEGRATE. IMPLANT FAILURE FORMS NOT FILLED IN COMPLETELY. RADIOGRAPHS ARE MISSING. REPEATED ATTEMPTS TO OBTAIN WERE MADE.
Patient problems: Failure of Implant
MAUDE report 9571984 ↗InjuryNov 7, 2019Failure to Osseointegrate; Failure to Osseointegrate
DENTAL IMPLANT DID NOT OSSEOINTEGRATE. RADIOGRAPHS ARE MISSING. REPEATED ATTEMPTS TO OBTAIN WERE MADE.
Patient problems: Failure of Implant
MAUDE report 9294079 ↗InjuryNov 7, 2019Failure to Osseointegrate; Failure to Osseointegrate
DENTAL IMPLANT DID NOT OSSEOINTEGRATE. RADIOGRAPHS ARE MISSING. REPEATED ATTEMPTS TO OBTAIN WERE MADE.
Patient problems: Failure of Implant
MAUDE report 9294078 ↗InjuryNov 7, 2019Failure to Osseointegrate; Failure to Osseointegrate
DENTAL IMPLANT DID NOT OSSEOINTEGRATE. RADIOGRAPHS ARE MISSING. REPEATED ATTEMPTS TO OBTAIN WERE MADE.
Patient problems: Failure of Implant
MAUDE report 9294075 ↗InjuryNov 7, 2019Failure to Osseointegrate; Failure to Osseointegrate
DENTAL IMPLANT DID NOT OSSEOINTEGRATE. RADIOGRAPHS ARE MISSING. REPEATED ATTEMPTS TO OBTAIN WERE MADE.
Patient problems: Failure of Implant
MAUDE report 9294074 ↗InjuryNov 7, 2019Failure to Osseointegrate; Failure to Osseointegrate
DENTAL IMPLANT DID NOT OSSEOINTEGRATE. RADIOGRAPHS ARE MISSING. REPEATED ATTEMPTS TO OBTAIN WERE MADE.
Patient problems: Failure of Implant
MAUDE report 9294073 ↗InjuryNov 7, 2019Failure to Osseointegrate; Failure to Osseointegrate
DENTAL IMPLANT DID NOT OSSEOINTEGRATE. RADIOGRAPHS ARE MISSING. REPEATED ATTEMPTS TO OBTAIN WERE MADE.
Patient problems: Failure of Implant
MAUDE report 9294071 ↗InjuryNov 7, 2019Failure to Osseointegrate; Failure to Osseointegrate
DENTAL IMPLANT DID NOT OSSEOINTEGRATE. RADIOGRAPHS ARE MISSING. REPEATED ATTEMPTS TO OBTAIN WERE MADE.
Patient problems: Failure of Implant
MAUDE report 9294066 ↗InjuryNov 7, 2019Failure to Osseointegrate; Failure to Osseointegrate
DENTAL IMPLANT DID NOT OSSEOINTEGRATE. RADIOGRAPHS ARE MISSING. REPEATED ATTEMPTS TO OBTAIN WERE MADE.
Patient problems: Failure of Implant
MAUDE report 9294064 ↗InjuryNov 7, 2019Failure to Osseointegrate; Failure to Osseointegrate
DENTAL IMPLANT DID NOT OSSEOINTEGRATE. THE DENTIST SENT TITAN IMPLANTS A LUMP SUM OF DENTAL IMPLANTS AND LIST OF PATIENT NAMES; CLAIMING THE IMPLANTS DID NOT OSSEOINTEGRATE. IMPLANT FAILURE FORMS WERE PROVIDED TO THE DENTIST. THUS FAR, IMPLANT FAILURE FORMS AND RADIOGRAPHS ARE MISSING. NO INFORMATION ON PATIENT PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9294058 ↗InjuryNov 7, 2019Failure to Osseointegrate; Failure to Osseointegrate
DENTAL IMPLANT DID NOT OSSEOINTEGRATE. THE DENTIST SENT TITAN IMPLANTS A LUMP SUM OF DENTAL IMPLANTS AND LIST OF PATIENT NAMES; CLAIMING THE IMPLANTS DID NOT OSSEOINTEGRATE. IMPLANT FAILURE FORMS WERE PROVIDED TO THE DENTIST. THUS FAR, IMPLANT FAILURE FORMS AND RADIOGRAPHS ARE MISSING. NO INFORMATION ON PATIENT PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9294057 ↗InjuryNov 7, 2019Failure to Osseointegrate; Failure to Osseointegrate
DENTAL IMPLANT DID NOT OSSEOINTEGRATE. THE DENTIST SENT TITAN IMPLANTS A LUMP SUM OF DENTAL IMPLANTS AND LIST OF PATIENT NAMES; CLAIMING THE IMPLANTS DID NOT OSSEOINTEGRATE. IMPLANT FAILURE FORMS WERE PROVIDED TO THE DENTIST. THUS FAR, IMPLANT FAILURE FORMS AND RADIOGRAPHS ARE MISSING. NO INFORMATION ON PATIENT PROVIDED.
Patient problems: Failure of Implant
MAUDE report 9294056 ↗InjuryNov 7, 2019Failure to Osseointegrate; Failure to Osseointegrate
DENTAL IMPLANT DID NOT OSSEOINTEGRATE. THE DENTIST SENT TITAN IMPLANTS A LUMP SUM OF DENTAL IMPLANTS AND LIST OF PATIENT NAMES; CLAIMING THE IMPLANTS DID NOT OSSEOINTEGRATE. IMPLANT FAILURE FORMS WERE PROVIDED TO THE DENTIST. THUS FAR, IMPLANT FAILURE FORMS AND RADIOGRAPHS ARE MISSING.
Patient problems: Failure of Implant
MAUDE report 9294054 ↗InjuryNov 7, 2019Failure to Osseointegrate; Failure to Osseointegrate
DENTAL IMPLANT DID NOT OSSEOINTEGRATE. THE DENTIST SENT TITAN IMPLANTS A LUMP SUM OF DENTAL IMPLANTS AND LIST OF PATIENT NAMES; CLAIMING THE IMPLANTS DID NOT OSSEOINTEGRATE. IMPLANT FAILURE FORMS WERE PROVIDED TO THE DENTIST. THUS FAR, IMPLANT FAILURE FORMS AND RADIOGRAPHS ARE MISSING. NO OTHER INFORMATION PROVIDED OTHER THAN PATIENT'S NAME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9294053 ↗InjuryNov 7, 2019Failure to Osseointegrate; Failure to Osseointegrate
DENTAL IMPLANT DID NOT OSSEOINTEGRATE. THE DENTIST SENT TITAN IMPLANTS A LUMP SUM OF DENTAL IMPLANTS AND LIST OF PATIENT NAMES; CLAIMING THE IMPLANTS DID NOT OSSEOINTEGRATE. IMPLANT FAILURE FORMS WERE PROVIDED TO THE DENTIST. THUS FAR, IMPLANT FAILURE FORMS AND RADIOGRAPHS ARE MISSING.
Patient problems: Failure of Implant
MAUDE report 9294052 ↗InjuryNov 7, 2019Failure to Osseointegrate; Failure to Osseointegrate
DENTAL IMPLANT DID NOT OSSEOINTEGRATE. THE DENTIST SENT TITAN IMPLANTS A LUMP SUM OF DENTAL IMPLANTS AND LIST OF PATIENT NAMES; CLAIMING THE IMPLANTS DID NOT OSSEOINTEGRATE. IMPLANT FAILURE FORMS WERE PROVIDED TO THE DENTIST. THUS FAR, IMPLANT FAILURE FORMS AND RADIOGRAPHS ARE MISSING.
Patient problems: Failure of Implant
MAUDE report 9293108 ↗InjuryNov 7, 2019Failure to Osseointegrate; Failure to Osseointegrate
DENTAL IMPLANT DID NOT OSSEOINTEGRATE. THE DENTIST SENT TITAN IMPLANTS A LUMP SUM OF DENTAL IMPLANTS AND LIST OF PATIENT NAMES; CLAIMING THE IMPLANTS DID NOT OSSEOINTEGRATE. IMPLANT FAILURE FORMS WERE PROVIDED TO THE DENTIST. THUS FAR, IMPLANT FAILURE FORMS AND RADIOGRAPHS ARE MISSING.
Patient problems: Failure of Implant
MAUDE report 9293103 ↗InjuryNov 7, 2019Failure to Osseointegrate; Failure to Osseointegrate
DENTAL IMPLANT DID NOT OSSEOINTEGRATE. THE DENTIST SENT TITAN IMPLANTS A LUMP SUM OF DENTAL IMPLANTS AND LIST OF PATIENT NAMES; CLAIMING THE IMPLANTS DID NOT OSSEOINTEGRATE. IMPLANT FAILURE FORMS WERE PROVIDED TO THE DENTIST. THUS FAR, IMPLANT FAILURE FORMS AND RADIOGRAPHS ARE MISSING.
Patient problems: Failure of Implant
MAUDE report 9293096 ↗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 9293036 ↗
Other Implant, Endosseous, Root-Form devices
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- 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.
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