USS 04.607.412Recalls & reported problems
Synthes GmbH · TI COLLAR FOR 6.0MM RODS FOR USS POLYAXIAL · Class 2 · Implant
All models of USS (15)
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 10705034736662), received between May 2, 2017 and May 2, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Unintended Movement” (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
- Unintended Movement1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 2, 2017Unintended Movement; Unintended Movement
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT IS REPORTED PATIENT WAS IMPLANTED WITH THE UNIVERSAL SPINE SYSTEM (USS) II AT UNKNOWN LEVELS ON (B)(6) 2017. X-RAY TAKEN ON (B)(6) 2017 REVEALED THAT THE POLYAXIAL 3D HEAD AND THE COLLAR HAD BECOME LOOSE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017 FOR REVISION. IT IS NOT KNOWN WHAT WAS IMPLANTED DURING THE REVISION PROCEDURE. CONCOMITANT MEDICAL PRODUCTS: TITANIUM NUT (PART 499.294, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) USS COLLAR. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: Failure of Implant
MAUDE report 6538978 ↗
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- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
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- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 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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