Versatile Implant Pack PVRH3711Recalls & reported problems
Surgikor, LLC · Ø3.75mm x L11.5mm, Hex Connection, Regular Platform with Cover Screw & Mount · Class 2 · Implant
Data updated Oct 13, 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 D824PVRH37110), received between Mar 28, 2020 and Mar 28, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Osseointegration Problem” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Osseointegration Problem1
Patient problems
- Failure of Implant1
- Inadequate Osseointegration1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 28, 2020Osseointegration Problem; Osseointegration Problem
FAILURE OF TWO IMPLANTS. TEETH AFFECTED WERE 28 AND 29. SURGERY NECESSARY TO PREVENT DAMAGE. PATIENT NEEDED TO RETURN FOR ANOTHER DENTAL APPOINTMENT TO FINISH THE PROCEDURE (I.E., REPLACE IMPLANT). DUE TO EVENT, PATIENT EXPERIENCED MILD PAIN, AND WHAT WERE PRESUMABLY THE IMPLANTS (NOT CLEAR, BUT STRONGLY SUGGESTED) WERE SAID TO BE "LOOSE, NOT INTEGRATED." IMPLANTS WERE RESTORED. THE TWO IMPLANTS WERE PLACED TOO CLOSE TO EACH OTHER, AND THIS IS BELIEVED TO HAVE CAUSED THE FAILURE.
Patient problems: Failure of Implant; Inadequate Osseointegration; Pain
MAUDE report 9892424 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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