ScrewPlant ImplantRecalls & reported problems across all models
Implant Direct Sybron Manufacturing LLC · 27 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 588
- Deaths reported
- 0
- Injuries reported
- 586
- Recalls
- 0
We found 27 models of ScrewPlant Implant by Implant Direct Sybron Manufacturing LLC in the FDA's device registry (GUDID). Together they are named in 588 adverse event reports in the FDA's MAUDE database, received between May 2, 2018 and Sep 24, 2024 — classified as 586 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (383 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 ScrewPlant Implant problems
Device problems
- Failure to Osseointegrate383
- Loss of Osseointegration109
- Osseointegration Problem58
- Fracture16
- Positioning Problem14
- Positioning Failure4
- Adverse Event Without Identified Device or Use Problem2
- Device Appears to Trigger Rejection2
Patient problems
- Failure of Implant586
- Pain285
- Osteopenia/ Osteoporosis173
- No Consequences Or Impact To Patient59
- Edema28
- Inflammation23
- Unspecified Infection19
- Insufficient Information17
ScrewPlant Implant models
27 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ScrewPlant® Implant 104710Implant, Endosseous, Root-Form99 reports
- ScrewPlant® Implant 103710Implant, Endosseous, Root-Form88 reports
- ScrewPlant® Implant 104708Implant, Endosseous, Root-Form54 reports
- ScrewPlant® Implant 103711Implant, Endosseous, Root-Form50 reports
- ScrewPlant® Implant 103713Implant, Endosseous, Root-Form43 reports
- ScrewPlant® Implant 104711Implant, Endosseous, Root-Form43 reports
- ScrewPlant® Implant 104713Implant, Endosseous, Root-Form43 reports
- ScrewPlant® Implant 103708Implant, Endosseous, Root-Form40 reports
- 25 reports
- 21 reports
- ScrewPlant® Implant 105708Implant, Endosseous, Root-Form16 reports
- ScrewPlant® Implant 105710Implant, Endosseous, Root-Form14 reports
- 9 reports
- ScrewPlant® Implant 104716Implant, Endosseous, Root-Form7 reports
- 5 reports
- 5 reports
- ScrewPlant® Implant 103716Implant, Endosseous, Root-Form4 reports
- ScrewPlant® Implant 105711Implant, Endosseous, Root-Form4 reports
- ScrewPlant® Implant 105713Implant, Endosseous, Root-Form4 reports
- 3 reports
- 2 reports
- 2 reports
- 2 reports
- ScrewPlant® Implant 113713Implant, Endosseous, Root-Form2 reports
- 1 report
- 1 report
- ScrewPlant® Implant 113711Implant, Endosseous, Root-Form1 report
Recent ScrewPlant Implant adverse event reports
The 15 most recent reports across all models, 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
InjurySep 8, 2023Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Fibrosis; Granuloma; Osteopenia/ Osteoporosis
MAUDE report 17710884 ↗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 ↗InjuryMay 2, 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; Inflammation; Osteopenia/ Osteoporosis; Pain
MAUDE report 16854799 ↗InjuryJan 24, 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
MAUDE report 16231150 ↗InjuryDec 27, 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 16052517 ↗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 15667100 ↗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 15667071 ↗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 15667040 ↗InjuryOct 25, 2022Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 15665031 ↗
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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