NA 204.750Recalls & reported problems
Synthes GmbH · 3.5MM PELVIC CORTEX SCREW SELF-TAPPING 150MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982146229), received between May 6, 2025 and May 7, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE REPLACEMENT DRIVE CAPS WERE VERY WORN. 4 CANNULATED SCREWS BROKE IN DISTAL FEMUR, WERE NOT CHARGED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21980004 ↗MalfunctionMay 7, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE REPLACEMENT DRIVE CAPS WERE VERY WORN. 4 CANNULATED SCREWS BROKE IN DISTAL FEMUR, WERE NOT CHARGED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21979781 ↗MalfunctionMay 6, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE REPLACEMENT DRIVE CAPS WERE VERY WORN. 4 CANNULATED SCREWS BROKE IN DISTAL FEMUR, WERE NOT CHARGED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21970637 ↗
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- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-PLF40Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
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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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