ScrewPlant® Implant 104713PRecalls & reported problems
Implant Direct Sybron Manufacturing LLC · 4.7mm x 13mmL, 4.7mmD Platform (P) · Implant
All models of ScrewPlant Implant (27)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841307105138), received between Apr 5, 2019 and May 18, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).
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.
Most reported problems
Device problems
- Device Appears to Trigger Rejection1
- Failure to Osseointegrate1
- Osseointegration Problem1
Patient problems
- Failure of Implant2
- Foreign Body Reaction1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2021Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), BEFORE CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 11840842 ↗InjuryApr 5, 2019Device Appears to Trigger Rejection; Failure to Osseointegrate; Device Appears to Trigger Rejection; Failure to Osseointegrate
PER COMPLAINT (B)(4), A PATIENT WITH A DENTAL IMPLANT EXPERIENCED AN ALLERGIC REACTION AND INFECTION. OSSEOINTEGRATION FAILURE WAS ALSO REPORTED. THE IMPLANT WAS EXPLANTED FIVE MONTHS AFTER INITIAL PLACEMENT.
Patient problems: Failure of Implant; Foreign Body Reaction; Unspecified Infection
MAUDE report 8488511 ↗
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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