VECTRA 04.613.014Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034737041), received between May 30, 2017 and May 30, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Bent” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2017Bent; Bent

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL PROCEDURE FOR CERVICAL RADICULOPATHY ON (B)(6) 2017. DURING THE PROCEDURE, A SCREW WAS BEING INSERTED INTO THE TITANIUM (TI) VECTRA PLATE 1 LEVEL/14MM AND IT WAS NOTICED THAT THE LOCKING CLIP IN ONE OF THE PLATE HOLES WAS BENT AND HAD PARTIALLY MIGRATED OUT OF THE PLATE. THE SCREW WAS REMOVED FROM THE PLATE AS WELL AS ANOTHER SCREW WHICH WAS ALREADY IMPLANTED IN ANOTHER HOLE. THE PLATE WAS REMOVED. AS A RESULT THERE WAS A FIVE (5) MINUTE SURGICAL DELAY. A NEW 14MM VECTRA PLATE WAS USED AND THE TWO SCREWS THAT WERE REMOVED WERE RE-IMPLANTED. NO FRAGMENTS WERE GENERATED. NO PATIENT HARM AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS STABLE. CONCOMITANT DEVICES REPORTED: SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6597939 ↗

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-