ScrewIndirect® Implant 404708Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10841307104803), received between Dec 1, 2020 and Apr 5, 2026 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Osseointegrate” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2026Fracture

  COMPONENT FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787116 ↗
• InjuryApr 5, 2026Migration

  PART MIGRATES.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787089 ↗
• InjuryJan 21, 2026Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24131623 ↗
• InjuryJan 3, 2026Positioning Failure; Osseointegration Problem

  LACK OF STABILITY DURING PLACEMENT.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23953095 ↗
• InjuryJan 3, 2026Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23953093 ↗
• MalfunctionJan 3, 2026Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23953087 ↗
• InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23474510 ↗
• InjuryOct 23, 2024Malposition of Device; Malposition of Device

  PRIMARY STABILITY COULDN¿T BE ACHIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517955 ↗
• InjuryAug 12, 2024Failure to Osseointegrate; Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19966993 ↗
• InjuryAug 12, 2024Failure to Osseointegrate; Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19966741 ↗
• InjuryNov 2, 2022Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 15716938 ↗
• InjuryAug 8, 2022Positioning Failure; Positioning Failure

  (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.

  Patient problems: Failure of Implant; Granuloma

  MAUDE report 15183780 ↗
• InjuryFeb 24, 2022Positioning Failure; Positioning Failure

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.

  Patient problems: Failure of Implant

  MAUDE report 13589617 ↗
• InjuryJun 18, 2021Positioning Failure; Positioning Failure

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.

  Patient problems: Failure of Implant

  MAUDE report 12024343 ↗
• InjuryDec 1, 2020Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 10927909 ↗

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