Integra-CP 260-350-306Recalls & reported problems
Bicon, LLC · 5.0 x 6.0mm Integra-CP Implant - 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 00813110022837), received between Mar 15, 2023 and Apr 5, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate1
- Patient Device Interaction Problem1
Patient problems
- Inadequate Osseointegration2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 5, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
ACCORDING TO DENTIST, THE PATIENT CAME IN FOR CLEANING AT IMPLANT #30; HAD CLASS 3 MOBILITY BUT NO OCCLUSAL CONTACTS. REPORTED IMPLANT IS FAILING REQUIRING REMOVAL AND REPLACEMENT.
Patient problems: Inadequate Osseointegration
MAUDE report 19053479 ↗InjuryMar 15, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT WAS INSERTED INTO SITE #5 UNDER BICON PROTOCOL AND USING BICON REAMERS. THE SITE WAS COVERED AND SUTURED, WAITING FOR 2ND STAGE UNCOVERING AND RESTORATION. AFTER A 5-MONTH HEALING PERIOD, THE PATIENT PRESENTED FOR THE 2ND STAGE, AND THE IMPLANT WAS COMPLETELY NON-INTEGRATED, FLOATING IN GRANULOMATOUS TISSUE WITH MILD PURULENCE. THE FIXTURE WAS EXPLANTED, THE SITE CLEANED AND BONE GRAFT WITH MEMBRANE PLACED.
Patient problems: Inadequate Osseointegration
MAUDE report 16544665 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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