Millennium 1-70542Recalls & reported problems
Avalign Technologies, Inc. · Graves Vaginal Speculum, x-large, 12" · Class 1
Quick summary
This Graves vaginal speculum is a reusable metal surgical instrument used to hold the vagina open during exams. The 38 reports filed under this identifier describe dental implant problems instead — mainly implants that fail to fuse with the bone and are later lost, along with bone breakdown, inflammation and infection. No deaths and no device malfunctions are reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00190776387174), received between Aug 6, 2025 and May 23, 2026 — classified as 38 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (21 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 Osseointegrate21
- Loss of Osseointegration13
- Fracture2
- Malposition of Device2
- Patient-Device Incompatibility2
- Migration or Expulsion of Device1
Patient problems
- Failure of Implant38
- Osteolysis12
- Inflammation5
- Unspecified Infection4
- Sinus Perforation1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
InjuryMay 23, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 25264809 ↗InjuryMay 19, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 25219932 ↗InjuryApr 6, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24789820 ↗InjuryMar 30, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24730964 ↗InjuryMar 30, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24729692 ↗InjuryMar 30, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24728879 ↗InjuryMar 30, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24727379 ↗InjuryMar 24, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24676643 ↗InjuryFeb 12, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.
Patient problems: Failure of Implant
MAUDE report 24327896 ↗InjuryFeb 12, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. CUSTOMER REPORTED THAT THE IMPLANT PLACEMENT WAS A DELAYED IMPLANT PLACEMENT AFTER A SOLID PRESERVATION, HOWEVER, THE BONE QUALITY WAS NOT FAVORABLE, THERE WAS NO PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 24323009 ↗InjuryFeb 11, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.
Patient problems: Failure of Implant
MAUDE report 24318104 ↗InjuryFeb 6, 2026Failure to Osseointegrate
IT WAS REPORTED THAT THE IMPLANT FAILED TO OSTEO INTERGRATE AFTER SURGERY.
Patient problems: Failure of Implant
MAUDE report 24277144 ↗InjuryFeb 3, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24245543 ↗InjuryJan 21, 2026Malposition of Device
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FAILURE. IMPLANT PLACED TOO DEEP.
Patient problems: Failure of Implant
MAUDE report 24140168 ↗InjuryDec 29, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FAILURE.
Patient problems: Failure of Implant
MAUDE report 23907322 ↗InjuryDec 29, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FAILURE.
Patient problems: Failure of Implant
MAUDE report 23907308 ↗InjuryDec 24, 2025Migration or Expulsion of Device; Failure to Osseointegrate; Malposition of Device; Migration or Expulsion of Device; Failure to Osseointegrate; Malposition of Device
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS- DISLOCATION OF THE IMPLANT INTO THE MAXILLARY SINUS.
Patient problems: Failure of Implant; Sinus Perforation
MAUDE report 23889506 ↗InjuryDec 24, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23888921 ↗InjuryDec 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23818673 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23480618 ↗InjuryNov 3, 2025Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation; Osteolysis
MAUDE report 23452647 ↗InjuryNov 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23449946 ↗InjuryNov 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23447310 ↗InjuryOct 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 23424510 ↗InjuryOct 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 23424215 ↗
Other Speculum, Vaginal, Metal devices
- V. Mueller GL11Steris Corporation · SPECULUM, VAGINAL, METAL1 recall1 report
- Sklar Instruments 96-2605Sklar Corporation · SPECULUM, VAGINAL, METAL1 recall0 reports
- 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.