NA 214.080Recalls & reported problems
Synthes GmbH · 4.5MM CORTEX SCREW 80MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982153708), received between Oct 28, 2022 and Jan 6, 2026 — classified as 3 injuries.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- Nonunion/Delayed-union Bone Fracture3
- Malunion of Bone2
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 6, 2026Break
IT WAS REPORTED THAT THERE WAS HARDWARE REMOVAL DUE TO TWO BROKEN SCREWS. THE PATIENT HAD NON AND MAL-UNION.
Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture
MAUDE report 23973648 ↗InjuryJan 6, 2026Break
IT WAS REPORTED THAT THERE WAS HARDWARE REMOVAL DUE TO TWO BROKEN SCREWS. THE PATIENT HAD NON AND MAL-UNION.
Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture
MAUDE report 23973647 ↗InjuryOct 28, 2022Break; Break
IT WAS REPORTED THAT ON (B)(6) 2022, REVISION SURGERY OCCURRED DUE TO A BROKE SCREW, BROKEN PLATE, AND NON-UNION OF THE FRACTURE. IT IS UNKNOWN WHEN THE DEVICES WERE ORIGINALLY IMPLANTED. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE 4.5MM CORTEX SCREW 80MM. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 15693200 ↗
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- 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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