NA 04.161.001Recalls & reported problems
Synthes GmbH · TI OCCIPITAL PLATE-MEDIAL 50MM WIDTH · 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 10705034733432), received between Jul 5, 2022 and Aug 14, 2023 — classified as 2 injuries.
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 18, 2026.
Most reported problems
Device problems
- Material Integrity Problem1
- Patient Device Interaction Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 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) TI OCCIPITAL PLATE-MEDIAL 50MM WIDTH THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 17541770 ↗InjuryJul 5, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A PRIMARY PCF PROCEDURE IN THE OCCIPITAL REGION. LATER, ON AN UNKNOWN DATE, IT WAS DISCOVERED THAT THE PLATE AND SCREWS HAD COME OFF THE LESION. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. THIS REPORT IS FOR A TI OCCIPITAL PLATE-MEDIAL 50MM WIDTH. THIS IS REPORT 1 OF 3 FOR (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14915515 ↗
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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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