NA 04.601.110Recalls & reported problems
Synthes GmbH · 4.5MM TI OCCIPITAL SCREW 10MM · Class 2 · Implant
Data updated Oct 16, 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 10705034734309), received between Jul 5, 2022 and Dec 18, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient Device Interaction 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem2
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.
InjuryDec 18, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR CERVICAL FUSION (O-C4) ON (B)(6) 2023 THAT WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. ON (B)(6) 2023 THE PATIENT CAME TO THE OUTPATIENT CLINIC, WHERE IT WAS DISCOVERED THAT THE TWO SCREWS IN QUESTION HAD LOOSENED FROM THE OCCIPITAL BONE. REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2023 TO REPLACE THE OCCIPITAL BONE PLATE AND THE BONE SCREWS IN QUESTION. THE CAUSE OF THE LOOSENING IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 4.5MM TI OCCIPITAL SCREW 10MM. THIS IS REPORT 1 OF 4 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18346006 ↗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 10MM. THIS IS REPORT 3 OF 3 FOR (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14915527 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
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- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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