VECTRA 04.613.384Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034737553), received between Oct 11, 2018 and Oct 11, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionOct 11, 2018Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CERVICAL FUSION PROCEDURE ON (B)(6) 2018, ONE (1) TITANIUM VECTRA PLATE HAD A DEFECTIVE LOCKING MECHANISM. FIVE (5) TITANIUM CERVICAL SELF-RETAIN SCREWS WERE ALSO USED. WHEN PLACING THE FIFTH SCREW, THE ELGILOY CLIP OF THE PLATE ON THE LOCKING MECHANISM BROKE. THE PLATE AND ALL FIVE (5) SCREWS WERE THEN REMOVED. IT WAS AN ISSUE WITH THE CLIP NOT WITH THE SCREWS. THE PLATE WAS REMOVED AND A COMPETITOR¿S PLATE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO PATIENT HARM. CONCOMITANT DEVICE: 4.0MM TITANIUM CERVICAL SELF-RETAIN SCREW 16MM (PART 04.613.616, LOT UNKNOWN, QUANTITY 5). THIS REPORT IS FOR ONE (1) TITANIUM VECTRA PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7958625 ↗

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-