ScrewIndirect® Implant 403716Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10841307104797), received between Sep 6, 2018 and Mar 11, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Osseointegrate” (3 reports).

4 other recalls cover devices cleared under the same FDA submission (K061319); they may or may not involve this specific model.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2025Failure to Osseointegrate; Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant

  MAUDE report 21578356 ↗
• InjuryDec 1, 2022Positioning Failure; Positioning Failure

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, THERE WAS A CHANGE IN THE SIZE OF IMPLANT.

  Patient problems: Failure of Implant

  MAUDE report 15897553 ↗
• InjuryMay 25, 2021Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant

  MAUDE report 11877180 ↗
• InjurySep 13, 2019Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, IT WAS OBSERVED THAT PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.

  Patient problems: Failure of Implant; No Information

  MAUDE report 9022167 ↗
• MalfunctionSep 6, 2018Separation Problem; Separation Problem

  PER COMPLAINT (B)(4), DURING THE OSTEOTOMY, THE IMPLANT BECAME STUCK MIDWAY. THE DOCTOR WAS UNABLE TO REMOVE THE IMPLANT WITHOUT DAMAGING THE IMPLANT OR INSTRUMENTS. THERE WAS NO ADVERSE IMPACT TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7853733 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061319. One submission often covers many models, so check the product and lot details in each record.

• Z-0010-2020 · Aug 7, 2018 · Terminated
  ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousa
• Z-2376-2018 · May 18, 2018 · Terminated
  REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
• Z-2125-2017 · May 2, 2017 · Terminated
  Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
• Z-2320-2016 · Jul 5, 2016 · Terminated
  RePlant Angled Abutment Part Number 6050-52-60