KLOCKNER 10 40 12Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08435451602978), received between Jun 18, 2025 and Jun 18, 2025 — 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2025Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THAT ON THE (B)(6) 2017 THE IMPLANT WAS PLACED IN POSITION #2 AND THEN ON THE (B)(6) 2018 HE PLACED AN ABUTMENT APPLYING 30NCM TORQUE AND THAT IT SHOWED IDEAL CLINICAL STABILITY, ABSENCE OF MOBILITY, ABSENCE OF RADIOLUCID RADRIOGRAPHIC IMAGES AND ABSENCE OF SYMPTOMATOLOGY. THEN, ON THE (B)(6) /2018 THE PROSTHESIS WAS PLACED. HOWEVER, ON THE (B)(6) 2018 HE HAD TO EXTRACT THE IMPLANT SINCE THE PATIENT REPORTS THAT AT MASTICATION HE FELT THE CROWN LOSE AND HE TRIED TO REMOVE IT BY HIMSELF AND PAIN STARTED. THE PATIENT EXPERIENCED PAIN AND INFLAMATION, AT MASTICATION, FEW DAYS BEFORE THE IMPLANT WAS REMOVED. A NORMAL SURGICAL PROCEDURE WAS APPLIED.

  Patient problems: Difficulty Chewing

  MAUDE report 22284575 ↗