Advantim 18080304Recalls & reported problems
Microport Orthopedics Inc. · CANCELLOUS 6.5MM SELF-TAPPING BONE SCREW 3.5cm LENGTH · Class 2
All models of Advantim (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M684180803041), received between Oct 16, 2019 and Dec 6, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information2
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bone Fracture(s)1
- Hip Fracture1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 6, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO UNKNOWN REASONS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12933137 ↗InjuryOct 16, 2019Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information
ALLEGEDLY THE PATIENT WAS REVISED DUE TO MULTIPLE HIP DISLOCATIONS, HAVING A FAILED ACETABULAR. (RIGHT) ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019: (B)(4) ALLEGEDLY, PERIPROSTHETIC FRACTURE OF THE ACETABULAR COMPONENT PATIENT WAS SEEN IN CLINIC POST SX BETWEEN (B)(6) 2013. IMPROVEMENTS WERE SLOW AND THE PATIENT WAS NOT FULLY WEIGHT BEANING. PATIENT WAS FOUND TO HAVE A FAILED ACETABULAR ON (B)(6) 2013, AND THE PATIENT UNDERWENT A REVISION WITH CAGE RECONSTRUCTION.
Patient problems: Bone Fracture(s); Hip Fracture; No Information
MAUDE report 9199994 ↗
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- 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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