VECTRA 04.613.130Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034737133), received between Sep 12, 2018 and Dec 11, 2018 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING A LEVEL 2 ANTERIOR CERVICAL DISCECTOMY AND FUSION, THE SURGEON WAS ADJUSTING A SCREW AND THE BLOCKING CLIP OF A VECTRA (TM) PLATE BROKE. THE SCREW DID NOT MALFUNCTION. THE SURGERY WAS DELAYED FOR 30 MINUTES. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICE: UNKNOWN SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) TI VECTRA(TM) PLATE 2 LEVEL/30MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8153027 ↗
• InjurySep 12, 2018Migration; Migration

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH FOUR (4) 4.0MM TITANIUM VECTRA CERVICAL SCREWS, ONE (1) TITANIUM (TI) VECTRA PLATE (1 LEVEL 16MM), AND ONE (1) SYNTHES SYNMESH CAGE ON (B)(6) 2017. ONE MONTH POSTOPERATIVELY, THERE WAS A FIXATION FAILURE; NO ADDITIONAL SYMPTOMS NOTED. IT WAS UNSPECIFIED WHICH OF THE DEVICES HAD MALFUNCTIONED. DUE TO THE PATIENT EXHIBITING NO SYMPTOMS, THE DEVICES CONTINUE TO BE IMPLANTED. CONCOMITANT DEVICES: TI VECTRA-PLATE 2 LEVEL 30MM (PART: 04.613.130, LOT: 9770147, QUANTITY: 2). 4.0MM TI CERVICAL SELF-RETAINING SCREW SELF DRILLING ANGLE 16MM (PART: 04.613.716, LOT: L175021, QUANTITY: 2). END RING 15MM DIAMETER 2.5 DEGREES TI (PART: 495.389, LOT: 9974194, QUANTITY: 1). END RING 15MM DIAMETER 2.5 DEGREES CONVEX TI (PART: 495.416, LOT: 9898108, QUANTITY: 1). THIS REPORT IS FOR A TI VECTRA(TM) PLATE 2 LEVEL/30MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7869137 ↗

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-