NA 201.814Recalls & reported problems
Synthes GmbH · 2.0MM CORTEX SCREW SELF-TAPPING 14MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982142979), received between Nov 7, 2023 and May 2, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 2, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEM WAS MISSING FROM THE MANUFACTURERS PACKAGING. CUSTOMER STATES THAT THE BAG/ENVELOPE THAT THE PRODUCT IS SUPPOSED TO BE IN WAS RECEIVED, BUT IT WAS MISSING THE SCREW. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21952153 ↗MalfunctionNov 7, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE ORDER CAME IN WITH AN EMPTY WRAPPER. THE REPLACEMENT PACKAGE ARRIVED AND UPON OPENING THE BOX WE FOUND THE PLASTIC PACKAGING WHERE THE SCREW SHOULD HAVE BEEN, TO BE SEALED BUT EMPTY. THERE WERE NO PATIENT INVOLVEMENT OR PROCEDURE. THIS REPORT IS FOR ONE (1) 2.0MM CORTEX SCREW SELF-TAPPING 14MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18085184 ↗
Other Screw, fixation, bone devices
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- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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