ScrewPlant® Implant 103710Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · 3.7mmD x 10mmL, 3.7mmD Platform · Class 2 · Implant
All models of ScrewPlant Implant (27)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Implant Direct ScrewPlant dental implant is a tooth-root replacement placed in the jawbone. All 88 reports are injuries, mostly describing the implant failing to bond with the bone, and many mention pain. No deaths are listed. 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
- 88
- Deaths reported
- 0
- Injuries reported
- 88
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 10841307104919), received between May 2, 2018 and Sep 24, 2024 — classified as 88 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (59 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 Osseointegrate59
- Loss of Osseointegration14
- Osseointegration Problem7
- Fracture4
- Positioning Problem2
- Adverse Event Without Identified Device or Use Problem1
- Positioning Failure1
Patient problems
- Failure of Implant86
- Pain42
- Osteopenia/ Osteoporosis21
- No Consequences Or Impact To Patient8
- Edema6
- Insufficient Information6
- No Information4
- Granuloma2
Recent adverse event reports
The 25 most recent of 88 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 20295067 ↗InjuryMar 19, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJun 21, 2023Fracture; Fracture
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 17168420 ↗InjuryJun 12, 2023Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Granuloma; Osteopenia/ Osteoporosis
MAUDE report 17105666 ↗InjuryMay 29, 2023Fracture; Fracture
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 17017296 ↗InjuryNov 8, 2022Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 15750964 ↗InjuryOct 25, 2022Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 15667149 ↗InjuryOct 25, 2022Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 15665024 ↗InjuryOct 25, 2022Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 15665015 ↗InjuryOct 25, 2022Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 15665010 ↗InjuryOct 19, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 15636638 ↗InjuryOct 7, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 15563357 ↗InjuryOct 6, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 15550457 ↗InjuryAug 12, 2022Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Granuloma; Osteopenia/ Osteoporosis
MAUDE report 15218048 ↗InjuryJan 31, 2022Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation; Wound Dehiscence
MAUDE report 13397445 ↗InjuryMay 21, 2021Positioning Problem; Positioning Problem
PER COMPLAINT (B)(4), BEFORE CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 11862551 ↗InjuryMay 21, 2021Osseointegration Problem; Osseointegration Problem
PER (B)(4), BEFORE CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 11862508 ↗InjuryMay 19, 2021Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 11848506 ↗InjuryMay 19, 2021Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 11848505 ↗InjuryMay 19, 2021Positioning Problem; Positioning Problem
PER COMPLAINT (B)(4), BEFORE CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 11848504 ↗InjuryMay 19, 2021Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 11848465 ↗InjuryJan 22, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Pain
MAUDE report 11214809 ↗InjuryJan 22, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Pain
MAUDE report 11214758 ↗InjuryJan 22, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 11214700 ↗InjuryJan 22, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Pain
MAUDE report 11214698 ↗
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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