VECTRA-ONE 04.613.178Recalls & reported problems
Synthes GmbH · TI VECTRA-ONE PLATE 2 LEVEL/28MM · Class 2 · Implant
Data updated Oct 18, 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 10705034737317), received between Oct 4, 2019 and Oct 4, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
- Device-Device Incompatibility1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 4, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TOP TITANIUM VARIABLE ANGLE SCREW ON A TWO (2) LEVEL TITANIUM VECTRA ONE PLATE WAS PARTIALLY PULLED OUT. THIS WAS DISCOVERED ON A SIX (6) WEEK POST-OP X-RAY AFTER THE PATIENT UNDERWENT AN ANTERIOR CERVICAL FUSION PROCEDURE ON (B)(6) 2019. THERE WAS NO DEFICIENCY, ALLEGATION, MALFUNCTION AGAINST THE TWO (2) LEVEL PLATE OTHER THAN THE CLIP DID NOT KEEP THE TOP SCREW LOCKED IN. THERE WAS NO PLAN OF REMOVING THE DEVICE. PROCEDURE OUTCOME IS UNKNOWN. PATIENT IS CLINICALLY FINE. CONCOMITANT DEVICE: UNKNOWN SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 2). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) TI VECTRA-ONE PLATE 2 LEVEL/28MMM. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Code Available
MAUDE report 9155541 ↗
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- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430113Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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