NA 04.614.128Recalls & reported problems
Synthes GmbH · 4.0MM TI CANCELLOUS POLYAXIAL SCREW 28MM · 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 10705034738635), received between Aug 14, 2023 and Aug 14, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Material Integrity Problem” (1 report).
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
- Material Integrity Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2023Material Integrity Problem; Material Integrity Problem
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023 A PATIENT UNDERWENT OCCIPUT TO C2 SYNAPSE HARDWARE REVISION PROCEDURE DUE TO C2 SCREWS APPEARED TO NEED REPLACING. DURING PROCEDURE WHILE ASSESSING THE IMPLANTS, 2 WERE BROKEN AND ALL HARDWARE REQUIRED REMOVING. ORIGINAL SURGERY WAS PERFORMED APPROXIMATELY 2 YEARS AGO. THE TISSUE BIOPSY FOR PATIENT IS REQUESTED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 4.0MM TI CANCELLOUS POLYAXIAL SCREW 28MM THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4)
Patient problems: Insufficient Information
MAUDE report 17541758 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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