Advantim 18080305Recalls & reported problems
Microport Orthopedics Inc. · CANCELLOUS 6.5MM SELF-TAPPING BONE SCREW 4.0cm LENGTH · Class 2
All models of Advantim (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M684180803051), received between Aug 6, 2019 and Mar 31, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Loss of Osseointegration1
Patient problems
- Insufficient Information1
- No Information1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 31, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
PT. DISLOCATED. REVISED CUP (REPOSITIONED). PRODUCT NO REVISED: PRODUCT ID: PHAPE242 PROFEMUR Z 6 LONG VARUS STEM, LOT: 1906933, QTY: 1.
Patient problems: Insufficient Information
MAUDE report 13970732 ↗InjuryJan 19, 2021Loss of Osseointegration; Loss of Osseointegration
ALLEGEDLY, THE PATIENT WAS REVISED DUE TO CHRONIC KNEE PAIN, LOOSENING OF STEM AND COMPONENTS. (LEFT KNEE).
Patient problems: Pain
MAUDE report 11196157 ↗InjuryAug 6, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
ALLEGEDLY THE PATIENT HAS DISLOCATED 3 TIMES, (B)(6) PA. THE ABOVE IMPLANTS WERE REMOVED FROM THE PATIENT AND REPLACED WITH STRYKERS. STRYKERS DUAL MOBILITY WAS USED WITH A 28MM + 7MM HEAD OF OURS.
Patient problems: No Information
MAUDE report 8865590 ↗
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- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 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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