ScrewPlus® Implant 203711Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · 3.7mmD x 11.5mmL, 4.7mmD Platform · Implant
All models of ScrewPlus Implant (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10841307105428), received between Sep 21, 2018 and Jan 20, 2021 — classified as 5 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (3 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 16, 2026.
Most reported problems
Device problems
- Failure to Osseointegrate3
- Break1
- Loss of Osseointegration1
Patient problems
- Failure of Implant5
- Osteopenia/ Osteoporosis4
- Pain2
- Impaired Healing1
- Inflammation1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJan 20, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Impaired Healing
MAUDE report 11200374 ↗InjuryJan 19, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Pain
MAUDE report 11191807 ↗InjuryNov 19, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Pain
MAUDE report 10867236 ↗InjurySep 11, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), PATIENT EXPERIENCED INFLAMMATION, BONE LOSS,INFECTION AND SWELLING. IMPLANT FAILED TO INTEGRATE.
Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 8987217 ↗InjurySep 21, 2018Break; Break
PER COMPLAINT (B)(4), THE LOCATOR BROKEN DOWN AND THE PROSTHESIS NO LONGER CLICKS. THIS RESULTED IN THE IMPLANT BEING REMOVED, BONE BY PLACE AND RE-IMPLANTED.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 7900249 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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