VECTRA 04.613.248Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034737416), received between Sep 3, 2020 and Sep 3, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical 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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO LOOSENING. ON (B)(6) 2020 THE PATIENT UNDERWENT A THREE LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) WHERE A 48MM VECTRA CERVICAL PLATE WAS IMPLANTED WITH EIGHT (8) 4.0X18 MM VECTRA VARIABLE ANGLE SCREWS. A FEW DAYS AFTER THE CASE THE PATIENT HAD A COUGHING ATTACK SIGNIFICANT ENOUGH TO VISIT THE ER. NO IMPLANT ISSUES WERE REPORTED AT THAT TIME. ON (B)(6) 2020 THE PATIENT VISITED THE CLINIC WITH DISCOMFORT IN HIS NECK. X-RAYS AND A CT SCAN WERE ORDERED AND THE LOOSE PLATE WITH THREE BACKED OUT SCREWS WAS DISCOVERED. BASED ON THE CT FINDINGS, THE IMPLANT LOOSENING APPEARED TO HAVE HAPPENED A MONTH OR MORE EARLIER DUE WHERE THE SCREW TRACKS WOULD HAVE BEEN. DURING THE REVISION PROCEDURE THE ORIGINAL IMPLANTS WERE REMOVED AND SUCCESSFULLY REPLACED WITH A 45MM VECTRA PLATE AND LONGER 4.5 X 20MM VECTRA SCREWS. IT IS BELIEVED THAT THE PATIENT SUFFERED NO INTERNAL DAMAGE FROM LOOSE HARDWARE BASED ON AN INSPECTION OF THE WOUND DURING THE REVISION PROCEDURE. THE EXPLANTED CERVICAL PLATE WAS BRIEFLY INSPECTED BY THE SURGEON AND DISCARDED; IT DID NOT APPEAR TO BE DAMAGED. THE SURGEON BELIEVES THAT TH

  Patient problems: Injury; No Code Available

  MAUDE report 10487595 ↗

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-