RePlant® Implant Analog 6035-06DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841307123897), received between Feb 8, 2019 and Oct 18, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Osseointegrate” (2 reports).

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2023Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4). AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis

  MAUDE report 17958055 ↗
• InjuryOct 18, 2023Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis

  MAUDE report 17958049 ↗
• MalfunctionFeb 8, 2019Component Misassembled; Component Misassembled

  PER COMPLAINT (B)(4), A DENTAL IMPLANT ANALOG WAS REPORTED TO BE INCORRECTLY MANUFACTURED. THE ORIENTATION OF THE ANALOG DID NOT ALIGN WITH A 3D-PRINTED MODEL.

  Patient problems: No Patient Involvement

  MAUDE report 8324057 ↗