NA 04.614.332Recalls & reported problems
Synthes GmbH · 3.5MM TI CORTEX POLYAXIAL SHAFT SCREW 32MM · 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 10705034739045), received between Apr 7, 2023 and Apr 7, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Integrity Problem” (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
- Material Integrity Problem2
Patient problems
- Pain2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 7, 2023Material Integrity Problem; Material Integrity Problem
DEVICE REPORT FROM PORTUGAL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT REVISION SURGERY DUE TO BROKEN SCREWS. PATIENT WAS ORIGINALLY TREATED SIX YEARS AGO FOR TUMOR WITH INSTABILITY IN C1/C2. ON AN UNKNOWN POSTOPERATIVE DATE, THE PATIENT RETURNED TO THE SURGEON COMPLAINING OF PAIN. EXAMS DETECTED THAT BOTH SCREWS IN C1 WERE BROKEN. IN THE REVISION SURGERY, THE IMPLANTS WERE REMOVED AND NEW STABILIZATION WAS PERFORMED WITH ANOTHER MATERIAL. THIS REPORT IS FOR A 3.5MM TI CORTEX POLYAXIAL SHAFT SCREW 32MM. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: Pain
MAUDE report 16701787 ↗InjuryApr 7, 2023Material Integrity Problem; Material Integrity Problem
DEVICE REPORT FROM PORTUGAL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT REVISION SURGERY DUE TO BROKEN SCREWS. PATIENT WAS ORIGINALLY TREATED SIX YEARS AGO FOR TUMOR WITH INSTABILITY IN C1/C2. ON AN UNKNOWN POSTOPERATIVE DATE, THE PATIENT RETURNED TO THE SURGEON COMPLAINING OF PAIN. EXAMS DETECTED THAT BOTH SCREWS IN C1 WERE BROKEN. IN THE REVISION SURGERY, THE IMPLANTS WERE REMOVED AND NEW STABILIZATION WAS PERFORMED WITH ANOTHER MATERIAL. THIS REPORT IS FOR A 3.5MM TI CORTEX POLYAXIAL SHAFT SCREW 32MM. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: Pain
MAUDE report 16701732 ↗
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- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
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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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