NA 02.206.032Recalls & reported problems
Synthes GmbH · 3.5MM CRTX SCREW/LOW PROF HD SELF-TAPPING/HEX DRIVE/32MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982050267), received between Oct 22, 2020 and Oct 22, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).
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
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT UPON PRODUCT RECEIPT AT MANUFACTURER'S INVESTIGATION SITE IT WAS IDENTIFIED THAT SEALED PACKAGE CONTAINS INCORRECT NUMBER OF SCREWS. THE 3.5MM CORTEX SCREW/LOW PROF HD SELF-TAPPING/HEX DRIVE/32MM PACKAGE LABELED FOR QUANTITY 1 BUT IT CONTAINED QUANTITY 2. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.5MM CRTX SCREW/LOW PROF HD SELF-TAPPING/HEX DRIVE/32MM. THIS IS REPORT 1 OF 1 FOR (B)(4)
Patient problems: No Patient Involvement
MAUDE report 10722562 ↗
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 STP3.5-350Nuvasive 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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