ScrewIndirect® Implant 403713Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø3.7 x 8 Platform 3.5mmD · Class 2 · Implant
All models of ScrewIndirect Implant (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Implant Direct ScrewIndirect implant is a screw-shaped device placed into bone. Its 187 reports include 184 injuries and no deaths, and most describe the implant failing to bond with the surrounding bone. Some also mention difficulty inserting or positioning the implant. Reports in the last 12 months (76) are well above the prior 12 months (16), and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 187
- Deaths reported
- 0
- Injuries reported
- 184
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 187 adverse event reports that list this exact device (DI 10841307104780), received between Jul 12, 2019 and Jun 25, 2026 — classified as 184 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (96 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate96
- Positioning Failure41
- Difficult to Insert15
- Adverse Event Without Identified Device or Use Problem14
- Osseointegration Problem10
- Loss of Osseointegration7
- Premature Separation6
- No Apparent Adverse Event5
Patient problems
- No Clinical Signs, Symptoms or Conditions95
- Failure of Implant82
- Inadequate Osseointegration62
- No Consequences Or Impact To Patient14
- Inflammation11
- Granuloma6
- Insufficient Information6
- Unspecified Infection6
Recent adverse event reports
The 25 most recent of 187 reports, in the reporter's own words as published by the FDA.
InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25631359 ↗InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25631356 ↗InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25628344 ↗InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 25627040 ↗InjuryJun 16, 2026Difficult to Insert; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25522648 ↗InjuryJun 16, 2026Difficult to Insert; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25522113 ↗InjuryJun 11, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 25480047 ↗InjuryJun 11, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 25479801 ↗InjuryApr 21, 2026Fracture
InjuryApr 21, 2026Material Deformation
PART/INTERFACE DEFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24940095 ↗InjuryApr 21, 2026No Apparent Adverse Event
InjuryApr 20, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24927550 ↗InjuryApr 20, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24927481 ↗InjuryApr 20, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24927343 ↗InjuryApr 17, 2026Labelling, Instructions for Use or Training Problem
USABILITY - WRONG PART USED
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24916826 ↗InjuryApr 6, 2026Premature Separation
COMPONENT NOT RETAINED ON MATING PART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24787178 ↗InjuryApr 5, 2026Premature Separation
COMPONENT NOT RETAINED ON MATING PART
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24787172 ↗InjuryApr 5, 2026Separation Failure
COMPONENT DOES NOT DISENGAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24787161 ↗InjuryApr 5, 2026Premature Separation
COMPONENT NOT RETAINED ON MATING PART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24787153 ↗InjuryApr 5, 2026Premature Separation
COMPONENT NOT RETAINED ON MATING PART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24787150 ↗InjuryApr 5, 2026Separation Failure
COMPONENT DOES NOT DISENGAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24787137 ↗InjuryApr 5, 2026No Apparent Adverse Event
InjuryApr 5, 2026No Apparent Adverse Event
InjuryApr 5, 2026Component Incompatible
COMPONENT DOES NOT FIT/ALIGN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24787095 ↗InjuryApr 5, 2026No Apparent Adverse Event
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 · TerminatedImplantDirect 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 · TerminatedREPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
- Z-2125-2017 · May 2, 2017 · TerminatedLegacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
- Z-2320-2016 · Jul 5, 2016 · TerminatedRePlant Angled Abutment Part Number 6050-52-60
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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