MillenniumRecalls & reported problems across all models
Avalign Technologies, Inc. · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 58
- Deaths reported
- 0
- Injuries reported
- 48
- Recalls
- 0
We found 14 models of Millennium by Avalign Technologies, Inc. in the FDA's device registry (GUDID). Together they are named in 58 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2018 and Sep 2, 2026 — classified as 48 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (26 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Millennium problems
Device problems
- Failure to Osseointegrate26
- Loss of Osseointegration17
- Fracture4
- Detachment of Device or Device Component3
- Material Fragmentation3
- Break2
- Malposition of Device2
- Material Integrity Problem2
Patient problems
- Failure of Implant46
- Osteolysis14
- Inflammation7
- No Clinical Signs, Symptoms or Conditions5
- Unspecified Infection5
- No Known Impact Or Consequence To Patient2
- Foreign Body In Patient1
- Insufficient Information1
Millennium models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Millennium 1-70542Speculum, Vaginal, Metal38 reports
- Millennium 1-70551SPECULUM, VAGINAL, METAL7 reports
- Millennium Z16113001Pin, Fixation, Threaded2 reports
- Millennium 85-2481559RONGEUR, MANUAL1 report
- Millennium 9560565RONGEUR, MANUAL1 report
- Millennium 85-1511023BIT, DRILL1 report
- Millennium 72-551410C-PFGTElectrosurgical, Cutting & Coagulation & Accessories1 report
- Millennium 1-1883CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY1 report
- Millennium 92-H0499Hook, ophthalmic1 report
- MILLENNIUM 2-4342OSTEOTOME1 report
- MILLENNIUM 0-47130FORCEPS, GENERAL & PLASTIC SURGERY1 report
- Millennium 1-74101Instruments, Dental Hand1 report
- Millennium 72-5223622B10Electrosurgical, Cutting & Coagulation & Accessories1 report
- Millennium 1-70543Speculum, Vaginal, Metal1 report
Recent Millennium adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50572194 ↗InjuryAug 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. Swelling was also reported.
Patient problems: Swelling/ Edema
MAUDE report 50483941 ↗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 ↗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, 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 ↗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 ↗MalfunctionMar 23, 2026Material Fragmentation; Material Integrity Problem
A COMPLAINT FROM CUSTOMER PLUM CREEK SURGERY CENTER FOR ONE (1) UNIT OF ITEM #1-1883 FROM LOT A407. A TOOTH BROKE OFF DURING NORMAL SURGERY INTRA-OP USE ON (B)(6) 2026. THERE WAS NO DEATH OR SERIOUS INJURY. THERE WAS NO PATIENT INTERVENTION. THE CONDITION OF THE PATIENT WAS FINE. THERE WAS A DELAY OF TWENTY MINUTES WITH NO IMPACT TO THE PATIENT. THE BROKEN TOOTH WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24670144 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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