ScrewIndirect® Implant 403013Recalls & 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 is a Sybron Implant Direct ScrewIndirect dental implant, a root-form screw placed into the jawbone to support a tooth. Most of the 39 reports describe the implant failing to fuse with the surrounding bone, or losing that bond after placement, along with the implant ending up in the wrong position or being hard to insert. Reports mention 38 injuries and no deaths. 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
- 39
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10841307104735), received between Jul 23, 2019 and Jun 24, 2026 — classified as 38 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (19 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.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate19
- Malposition of Device6
- Positioning Failure5
- Adverse Event Without Identified Device or Use Problem2
- Difficult to Insert2
- Loss of Osseointegration2
- Premature Separation2
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- Inadequate Osseointegration16
- Failure of Implant11
- Osteopenia/ Osteoporosis2
- Unspecified Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
InjuryJun 24, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25613959 ↗InjuryApr 26, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24993963 ↗InjuryApr 26, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24993955 ↗InjuryMar 19, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24644514 ↗InjuryMar 18, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 24628376 ↗InjuryMar 11, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 24568138 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474606 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474495 ↗InjuryNov 4, 2025Difficult to Insert; Difficult to Insert
PART/INTERFACE DOES NOT ENGAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23461589 ↗InjuryNov 4, 2025Difficult to Insert; Difficult to Insert
PART/INTERFACE DOES NOT ENGAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23461582 ↗InjuryNov 4, 2025Malposition of Device; Malposition of Device
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23461469 ↗InjuryNov 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
TRAUMA / CLINICAL COMPLICATION ONLY.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23436802 ↗InjuryOct 31, 2025Malposition of Device; Malposition of Device
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23436559 ↗InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
TRAUMA / CLINICAL COMPLICATION ONLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21144241 ↗InjuryJan 10, 2025Malposition of Device; Malposition of Device
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21131280 ↗InjuryJan 9, 2025Malposition of Device; Malposition of Device
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21120123 ↗InjuryJan 9, 2025Malposition of Device; Malposition of Device
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21120061 ↗InjuryJan 9, 2025Malposition of Device; Malposition of Device
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21119265 ↗InjuryDec 10, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20551457 ↗InjurySep 14, 2024Premature Separation; Premature Separation
DROPPED FROM THE IMPLANT DRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20219820 ↗InjurySep 14, 2024Premature Separation; Premature Separation
DROPPED FROM THE IMPLANT DRIVER
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20219804 ↗InjurySep 14, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20089427 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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