NA 214.900Recalls & reported problems
Synthes GmbH · 4.5MM CORTEX SCREW SELF-TAPPING 100MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982154910), received between Mar 14, 2018 and Mar 14, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break2
Patient problems
- Failure of Implant2
- Nonunion/Delayed-union Bone Fracture2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 14, 2018Break; Break
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018. THE PATIENT WAS INITIALLY IMPLANTED WITH FOUR (4) 4.5 MM SELF-TAPPING CORTEX SCREWS ON AN UNKNOWN DATE. TWO (2) SCREWS OUT OF THE FOUR (4) SCREWS BROKE POSTOPERATIVELY DUE TO A NONUNION OF PELVIS OSTEOTOMY. THE SURGEON REMOVED ALL THE FOUR SCREWS AND PUT IN NEW SCREWS AND PLATES. THERE IS NO INFORMATION PROVIDED REGARDING THE STATUS OF THE PATIENT AND THE PROCEDURE. CONCOMITANT DEVICE (S) REPORTED: 4.5MM CORTEX SCREW SELF-TAPPING 100MM (PART # 214.900, LOT # UNKNOWN, QTY 2). THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture
MAUDE report 7339141 ↗InjuryMar 14, 2018Break; Break
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018. THE PATIENT WAS INITIALLY IMPLANTED WITH FOUR (4) 4.5 MM SELF-TAPPING CORTEX SCREWS ON AN UNKNOWN DATE. TWO (2) SCREWS OUT OF THE FOUR (4) SCREWS BROKE POSTOPERATIVELY DUE TO A NONUNION OF PELVIS OSTEOTOMY. THE SURGEON REMOVED ALL THE FOUR SCREWS AND PUT IN NEW SCREWS AND PLATES. THERE IS NO INFORMATION PROVIDED REGARDING THE STATUS OF THE PATIENT AND THE PROCEDURE. CONCOMITANT DEVICE (S) REPORTED: 4.5MM CORTEX SCREW SELF-TAPPING 100MM (PART # 214.900, LOT # UNKNOWN, QTY 2). THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture
MAUDE report 7339135 ↗
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- 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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