VECTRA 04.613.016Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034737058), received between May 11, 2023 and Sep 26, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (2 reports).

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.

• MalfunctionSep 26, 2023Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6), 2023, THAT DURING PLACEMENT OF THE VECTRA PLATE AND SCREWS, SURGEON FOUND THAT HE COULD NOT ADVANCE A 4.0 TI CERV SLF RTN SCR SLF-TPNG/VA 16MM SCREW BEYOND THE LOCKING MECHANISM ON THE PLATE. FLUOROSCOPY WAS USED, EVERYTHING LOOKED ACCEPTABLE FOR SCREW PLACEMENT AND ANGULATION. HE REMOVED THE SCREW, AND ATTEMPTED TO PLACE A SHORTER RESCUE SCREW 4.5 TI CERV SLF RTN SCR SLF-TPNG/VA 14MM IN ITS PLACE. THAT SCREW WOULD ALSO NOT PASS THE LOCKING MECHANISM. HE REMOVED THE RESCUE SCREW AND INSPECTED THE PLATE VISUALLY, AND SAW DIFFERENCES BETWEEN THAT SCREW HOLE AND THE OTHERS. HE ELECTED TO REMOVE THE ENTIRE CONSTRUCT AND START NEW. THIS LED TO MORE 4.0 TI CERV SLF RTN SCR SLF-TPNG/VA 16MM IMPLANTS BEING WASTED AND ARE PART OF THIS COMPLAINT. THE SURGERY WAS EASILY COMPLETED WITH A MINIMAL AMOUNT OF EXTRA TIME (UNDER 5 MINUTES). NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) TI VECTRA(TM) PLATE 1 LEVEL/16MM. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821434 ↗
• MalfunctionMay 11, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  THERE WAS SURGICAL DELAY FOR 10 MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16912724 ↗

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-