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NA 04.601.112Recalls & reported problems

Synthes GmbH · 4.5MM TI OCCIPITAL SCREW 12MM · 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 10705034734316), received between Jul 5, 2022 and Jul 5, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction 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

  • Patient Device Interaction Problem1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • 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 4.5MM TI OCCIPITAL SCREW 12MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 14915487 ↗

Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices

All APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices →

Sources and updates

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