JDEvolution Plus JDEvolution Plus dental implant D 3.7 L 11.5Recalls & reported problems
J Dental Care Srl · JDEvolution Plus dental implant D 3.7 L 11.5 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08055510170080), received between Feb 12, 2025 and Feb 12, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Failure to Osseointegrate” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate1
Patient problems
- Inadequate Osseointegration1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT EV37115: WAS INSERTED IN POSITION 35 ON (B)(6)2025. THE PATIENT (FEMALE SEX, AGE 77) HAD NO SPECIAL CLINICAL CONDITIONS. INSERTION WAS PERFORMED WITH CONTRA-ANGLE USING AN END TORQUE OF 35 NCM. DURING THE SUBMERGED HEALING PERIOD, THERE WAS FAILURE TO OSSEOINTEGRATE THE IMPLANT, WHICH WAS THEREFORE SUBSEQUENTLY REMOVED. AT THE TIME OF REMOVAL, THE PATIENT FELT PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 21363187 ↗
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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