NA 201.687Recalls & reported problems
Synthes GmbH · 2.4MM CORTEX SCREW 3.5MM HEAD/SELF-TAPPING 34MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982142535), received between Sep 21, 2018 and Sep 21, 2018 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Erosion1
- Foreign Body In Patient1
- Not Applicable1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ON (B)(6) 2018, THE PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE DUE TO WOUND BREAK DOWN. THERE ARE FOUR (4) SELF TAPPING METAPHYSEAL SCREWS, FOUR (4) VARIABLE ANGLE (VA) SELF TAPPING LOCKING SCREWS, ONE (1) VA LARGE LOCKING CALCANEAL PLATE, AND ONE (1) SELF TAPPING CORTEX SCREW WERE REMOVED. ONE (1) SELF TAPPING CORTEX SCREW REMAINED IMPLANTED DUE TO UNKNOWN REASON. ORIGINALLY, THE HARDWARE WAS IMPLANTED ON (B)(6) 2018. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS OR SURGICAL DELAY IS UNKNOWN. THIS COMPLAINT INVOLVES ELEVEN (11) DEVICE. THE OTHER PARTS ASSOCIATED WITH THIS COMPLAINT ARE LOCATED IN (B)(4). THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: Erosion; Foreign Body In Patient; Not Applicable
MAUDE report 7897978 ↗
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- 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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