NA 202.826Recalls & reported problems
Synthes GmbH · 2.7MM CORTEX SCREW SELF-TAPPING 26MM · 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 10886982144799), received between Jan 6, 2023 and Jan 6, 2023 — 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
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT THE DEVICES IN 2016. THE PATIENT FOUND OUT THAT THERE WAS A PROBLEM WITH THE IMPLANTS APPROXIMATELY 2 MONTHS AGO WHEN HE WENT TO THE ER BECAUSE HIS ARM WAS BAD, AND X-RAYS WERE TAKEN. THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE HARDWARE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.7MM CORTEX SCREW SELF-TAPPING 26MM. THIS IS REPORT 1 OF 8 FOR (B)(4).
Patient problems: Failure of Implant
MAUDE report 16113688 ↗
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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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