Millennium 1-70551Recalls & reported problems
Avalign Technologies, Inc. · Virgin Pederson Vaginal Speculum, 9mm x 3" · Class 1
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00190776303136), received between Oct 27, 2025 and Jul 27, 2026 — classified as 7 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate4
- Loss of Osseointegration3
Patient problems
- Failure of Implant7
- Osteolysis2
- Inflammation1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. Also, it was reported that they had unspecified inflammation and Osteolysis.
Patient problems: Failure of Implant; Inflammation; Osteolysis
MAUDE report 50025714 ↗InjuryJul 2, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25699316 ↗InjuryJun 15, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25504442 ↗InjuryMar 30, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. LOSS OF MOBILITY AND PROGRESSIVE BONE LOSS WAS REPORTED.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 24737727 ↗InjuryFeb 12, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. CUSTOMER REPORTED THAT THE IMPLANT FAILED TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 24323038 ↗InjuryNov 12, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23538613 ↗InjuryOct 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23398857 ↗
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- Sklar® 96-3001Sklar Corporation · SPECULUM, VAGINAL, METAL1 recall0 reports
- V. Mueller GL31Steris Corporation · SPECULUM, VAGINAL, METAL1 recall0 reports
- Sklar® 96-2607Sklar Corporation · SPECULUM, VAGINAL, METAL1 recall0 reports
- Sklar Instruments 96-2613Sklar Corporation · SPECULUM, VAGINAL, METAL1 recall0 reports
- Sklar Instruments 96-2603Sklar Corporation · SPECULUM, VAGINAL, METAL1 recall0 reports
- Sklar Instruments 96-2615Sklar Corporation · SPECULUM, VAGINAL, METAL1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.