VECTRA 04.613.254Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034737430), received between Nov 2, 2018 and Jan 23, 2020 — classified as 2 injuries.

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 16, 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.

• InjuryJan 23, 2020No Apparent Adverse Event; No Apparent Adverse Event

  CONCOMITANT DEVICES REPORTED: UNK - SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1).

  Patient problems: No Code Available

  MAUDE report 9621600 ↗
• InjuryNov 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CLINICAL STUDY FOR A PATIENT THAT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY FUSION (ACDF) AT THE C4-C7 LEVELS ON (B)(6) 2018. THE PATIENT WAS IMPLANTED WITH A TITANIUM VECTRA PLATE, THREE (3) ADVANCED ACF SPACERS AND A VIVIGEN POUCH. ON (B)(6) 2018, THE PATIENT PRESENTED WITH C4-C5 INTERBODY FRACTURE OF FUSION MASS; ASYMPTOMATIC AT TIME OF EVALUATION. THIS REPORT IS FOR ONE (1) TI VECTRA(TM) PLATE 3 LEVEL/54MM. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 8034657 ↗

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-