Integra-CP 260-340-256Recalls & reported problems
Bicon, LLC · 4.0 x 6.0mm Integra-CP Implant - 2.5mm Well · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813110022608), received between Mar 17, 2026 and Mar 17, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Loss of Osseointegration” (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
- Loss of Osseointegration1
Patient problems
- Inadequate Osseointegration1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2026Loss of Osseointegration
ACCORDING TO THE ACCOUNT, THE PATIENT IS ALLERGIC TO PENICILLIN. THERE WERE MANY ADJUSTMENTS TO THE CROWN ON #9 OVER THE 2.5 YEARS. OVER TIME, BONE LOSS AND POSSIBLE BIOMECHANICAL OVERLOAD HAD COMPROMISED THE OSSEOINTEGRATION AS WELL AS PERI-IMPLANT INFECTION AT THE IMPLANT SITE RESULTING IN THE REMOVAL OF THE IMPLANT.
Patient problems: Inadequate Osseointegration
MAUDE report 24620081 ↗
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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 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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