KLOCKNER 18 35 10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08435451606839), received between Jun 18, 2025 and Jun 18, 2025 — 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 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, 2025Fracture; Fracture

  AT THE DATE OF PREPARATION OF THE REPORT IT HAS NOT BEEN POSSIBLE TO HAVE THE DENTAL IMPLANT AVAILABLE FOR TECHNICAL ANALYSIS AND, IN ADDITION, THE MANUFACTURER OF THE PROSTHESIS IS UNKNOWN, SO IT IS NOT POSSIBLE TO MAKE A HISTORY OF THE MATERIAL USED. THE DATA AVAILABLE TO DATE ARE THOSE RECORDED IN INCIDENT (B)(4) OF THE SAME DR. WITH A SIMILAR IMPLANT (18 35 12 LOT 26772-1124) AND THE DATA RECORDED IN THE QUALITY REPORT WHERE IT IS SPECIFIED THAT THE PATIENT IS A BRUXIST. AS HAS BEEN REFLECTED IN THIS INCIDENT, IF THE SEATING OF THE PROSTHESIS DOES NOT PRESENT THE FIT TOLERANCES AT THE IMPLANT-PROSTHESIS INTERFACE ESTABLISHED BY KLOCKNER® IMPLANT SYTEM, MICRO-MOVEMENTS ARE GENERATED BETWEEN BOTH SURFACES THAT WILL INDIRECTLY INDUCE A LOCALIZED OVERLOAD ON THE IMPLANT WITH EACH MASTICATION. THIS OVERLOAD WILL GENERATE A FRICTION AT THE IMPLANT-PROSTHESIS INTERFACE, WHICH WILL INDUCE A DEFECT ON THE IMPLANT SURFACE. THE SUCCESSIVE MASTICATORY LOADS WILL INDUCE THIS DEFECT TO START ITS PROPAGATION AND CONSEQUENTLY THE FAILURE OF THE IMPLANT.

  Patient problems: Implant Pain

  MAUDE report 22284585 ↗