ScrewIndirect® Implant 403708Recalls & 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 18, 2026 from official FDA records · Editorial policy
Quick summary
This Implant Direct ScrewIndirect dental implant is a root-form screw placed into the jawbone. The 69 reports mostly describe the implant failing to fuse with the bone, or losing that bond after it had formed, along with the fixture sitting in the wrong position and not staying attached to its mating part; some also mention inflammation and granuloma tissue. There are no deaths and 69 injuries, and no recalls name this device. Reports in the past 12 months (18) are more than twice the prior 12 months (8).
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
- 69
- Deaths reported
- 0
- Injuries reported
- 69
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 10841307104759), received between Nov 27, 2020 and Jul 29, 2026 — classified as 69 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (42 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.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate42
- Loss of Osseointegration8
- Positioning Failure7
- Osseointegration Problem5
- Malposition of Device4
- Adverse Event Without Identified Device or Use Problem3
- Difficult to Insert2
- Premature Separation1
Patient problems
- Failure of Implant35
- No Clinical Signs, Symptoms or Conditions28
- Inadequate Osseointegration25
- Inflammation11
- Granuloma9
- Osteopenia/ Osteoporosis7
- Unspecified Infection5
- Discomfort3
Recent adverse event reports
The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50073027 ↗InjuryApr 7, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24810935 ↗InjuryApr 5, 2026Premature Separation
COMPONENT NOT RETAINED ON MATING PART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24787133 ↗InjuryMar 20, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24654944 ↗InjuryMar 18, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 24628267 ↗InjuryMar 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24592073 ↗InjuryJan 21, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24132215 ↗InjuryJan 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23953091 ↗InjuryJan 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23953090 ↗InjuryJan 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23953089 ↗InjuryJan 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23953088 ↗InjuryNov 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23640386 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474502 ↗InjuryNov 4, 2025Difficult to Insert; Difficult to Insert
PART/INTERFACE DOES NOT ENGAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23462920 ↗InjuryNov 4, 2025Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem; Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem
TRAUMA / CLINICAL COMPLICATION ONLY.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23462827 ↗InjuryNov 4, 2025Positioning Failure; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Adverse Event Without Identified Device or Use Problem
TRAUMA / CLINICAL COMPLICATION ONLY.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23462821 ↗InjuryNov 4, 2025Positioning Failure; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Adverse Event Without Identified Device or Use Problem
TRAUMA / CLINICAL COMPLICATION ONLY.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23462819 ↗InjuryNov 4, 2025Difficult to Insert; Difficult to Insert
PART/INTERFACE DOES NOT ENGAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23461559 ↗InjuryOct 30, 2025Malposition of Device; Malposition of Device
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23430208 ↗InjuryOct 30, 2025Malposition of Device; Malposition of Device
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23430137 ↗InjuryOct 30, 2025Malposition of Device; Malposition of Device
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23430026 ↗InjuryOct 30, 2025Malposition of Device; Malposition of Device
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23429916 ↗InjuryApr 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Abscess; Inadequate Osseointegration
MAUDE report 21779028 ↗InjuryMar 5, 2025Positioning Failure; Positioning Failure
LACK OF PRIMARY STABILITY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21530282 ↗InjuryMar 5, 2025Positioning Failure; Positioning Failure
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21530271 ↗
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
Other Implant, Endosseous, Root-Form devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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