ScrewIndirect ImplantRecalls & reported problems across all models
Implant Direct Sybron Manufacturing LLC · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 705
- Deaths reported
- 0
- Injuries reported
- 696
- Recalls
- 0
We found 13 models of ScrewIndirect Implant by Implant Direct Sybron Manufacturing LLC in the FDA's device registry (GUDID). Together they are named in 705 adverse event reports in the FDA's MAUDE database, received between Sep 6, 2018 and Jul 29, 2026 — classified as 696 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (397 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ScrewIndirect Implant problems
Device problems
- Failure to Osseointegrate397
- Positioning Failure119
- Loss of Osseointegration45
- Osseointegration Problem39
- Difficult to Insert33
- Adverse Event Without Identified Device or Use Problem29
- Malposition of Device19
- Positioning Problem13
Patient problems
- Failure of Implant383
- No Clinical Signs, Symptoms or Conditions272
- Inadequate Osseointegration223
- Inflammation61
- Granuloma42
- Unspecified Infection41
- Osteopenia/ Osteoporosis39
- No Consequences Or Impact To Patient36
ScrewIndirect Implant models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ScrewIndirect® Implant 403710Implant, Endosseous, Root-Form241 reports
- ScrewIndirect® Implant 403713Implant, Endosseous, Root-Form187 reports
- ScrewIndirect® Implant 403708Implant, Endosseous, Root-Form69 reports
- ScrewIndirect® Implant 404710Implant, Endosseous, Root-Form51 reports
- ScrewIndirect® Implant 403010Implant, Endosseous, Root-Form50 reports
- ScrewIndirect® Implant 403013Implant, Endosseous, Root-Form39 reports
- ScrewIndirect® Implant 404713Implant, Endosseous, Root-Form22 reports
- ScrewIndirect® Implant 403008Implant, Endosseous, Root-Form15 reports
- ScrewIndirect® Implant 404708Implant, Endosseous, Root-Form15 reports
- ScrewIndirect® Implant 403716Implant, Endosseous, Root-Form5 reports
- ScrewIndirect® Implant 404716Implant, Endosseous, Root-Form5 reports
- ScrewIndirect® Implant 405710Implant, Endosseous, Root-Form5 reports
- ScrewIndirect® Implant 405708Implant, Endosseous, Root-Form1 report
Recent ScrewIndirect Implant adverse event reports
The 15 most recent reports across all models, 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 50073246 ↗InjuryJul 29, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50073027 ↗InjuryJun 26, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 25642299 ↗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 25631358 ↗InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25631357 ↗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 25631355 ↗InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 25629385 ↗InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 25628512 ↗InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25628358 ↗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; No Clinical Signs, Symptoms or Conditions
MAUDE report 25628324 ↗InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 25627040 ↗InjuryJun 24, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25613959 ↗
Other Implant Direct Sybron Manufacturing LLC products
- Legacy3 Implant75 models · 9,801 reports
- Legacy2 Implant78 models · 8,257 reports · 2 recalls
- simply InterActive Implant23 models · 4,946 reports
- simply Legacy2 Implant38 models · 3,319 reports
- RePlant Implant20 models · 2,351 reports
- SIMPLY ICONIC Implant39 models · 2,189 reports
- Legacy4 Implant58 models · 1,786 reports
- Legacy1 Implant27 models · 1,635 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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