Integra-CP 260-340-251Recalls & reported problems
Bicon, LLC · 4.0 x 11mm Integra-CP Implant - 2.5mm Well · Class 2 · Implant
Data updated Oct 18, 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 00813110022585), received between Nov 26, 2018 and Nov 26, 2018 — classified as 1 injury.
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 18, 2026.
Most reported problems
Device problems
- Fracture1
- Material Puncture/Hole1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 26, 2018Fracture; Material Puncture/Hole
ACCORDING TO DR. (B)(6), HE HAS AN IMPLANT WITH A FRACTURED FLOOR. HE SAID THE ABUTMENT HAS COME OUT MULTIPLE TIMES AND AT THE LAST VISIT, HE DISCOVERED THE FRACTURED WELL. HE GAVE THE HISTORY OF THE IMPLANT: "IMPLANT PLACED (B)(6) 2016 RESTORED ON (B)(6) 2016 ABUTMENT AND CROWN CAME OUT ON (B)(6) 2017 AGAIN (B)(6) 2018 AGAIN (B)(6) 2018 AGAIN (B)(6) 2018 AGAIN (B)(6) 2018 IT WAS THEN I TOOK A NEW IMPRESSION AND HAD A WHOLE NEW ABUTMENT AND CROWN MADE THINKING THAT SOMETHING WAS JUST NOT MILLED CORRECTLY IN THE ABUTMENT. AGAIN THE NEW ABUTMENT AND CROWN CAME OUT ON (B)(6) 2018 AND FINALLY BEING AT MY WITS END I DID SOME FURTHER INVESTIGATION AND FOUND THAT THE FLOOR OF THE WELL HAD A HOLE IN IT." HE CEMENTED THE ABUTMENT AT THE LAST VISIT BECAUSE HE WASN'T SURE WHAT TO DO.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8101483 ↗
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