VECTRA 04.613.138Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034737171), received between Dec 21, 2018 and Dec 8, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K050451); they may or may not involve this specific model.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN ANTERIOR CERVICAL FUSION FOR OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THERE WAS NO PROBLEM ON INSPECTION IN SEPTEMBER 2022. THE SCREWS IN QUESTION ARE CURRENTLY LOOSE. ALSO, THE PLATE IN QUESTION IS FLOATING A FEW MILLIMETERS FORWARD FROM THE VERTEBRAE. THE PATIENT IS SCHEDULED FOR REMOVAL AND RE-FIXATION ON (B)(6) 2023. THE PLATE WILL BE SHORTENED BY 2MM, AND THE SCREW WILL BE INCREASED BY 2MM FROM 16MM TO 18MM. THE PATIENT STATUS WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE TI VECTRA(TM) PLATE 2 LEVEL/38MM. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18290135 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD AN ALLERGIC REACTION TO DEVICES IMPLANTED AFTER AN UNKNOWN SURGERY. PATIENT HAD ITCHINESS, NEXT PATIENT TURNED RED AND HAD NUMBNESS FROM HIS NECK TO HIS LEFT SHOULDER. THE PATIENT WAS IMPLANTED WITH A TITANIUM VECTRA PLATE AND FOUR (4) TITANIUM SELF-DRILLING SCREWS ON (B)(6) 2015 FOR AN UNKNOWN PROCEDURE. THE PATIENT STATED THAT HE'S ALLERGIC TO NICKEL AND WANTS TO KNOW IF THE IMPLANTS CONTAINED THE MINERAL. THE SYMPTOMS OF RASH OCCURRED ALMOST IMMEDIATELY AFTER SURGERY. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) TI VECTRA(TM) PLATE 2 LEVEL/38MM. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Hypoesthesia; Itching Sensation

  MAUDE report 8188361 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050451. One submission often covers many models, so check the product and lot details in each record.

• Z-2674-2014 · Sep 2, 2014 · Terminated
  DePuy Synthes TI Vectra Plates: TI Vectra-One" Plate 2 Level / 34 mm part 04.613.184 3337672 TI Vectra" Plate 3 Level / 57 mm part 04.613.257 lot 3693878 TI Vectra" Plate 4
• Z-0781-2013 · Aug 6, 2012 · Terminated
  Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011. Sy
• Z-0782-2013 · Aug 6, 2012 · Terminated
  Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Part Number 03.613.012. Synthes Vectra System, Synthes Vectra-