VECTRA 04.613.251Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034737423), received between Sep 11, 2018 and Jun 24, 2019 — classified as 2 injuries, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THE INNER LOCKING MECHANISM OF A VECTRA 51 MM 3 LEVEL PLATE SHEARED OFF WHILE INSERTING A SELF-DRILLING VARIABLE ANGLE SCREW. THERE WERE FRAGMENTS GENERATED FROM BROKEN DEVICE. THE FRAGMENT WAS SECURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE: SELF-DRILLING VARIABLE ANGLE SCREW (PART/LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR A VECTRA 51 MM 3 LEVEL PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8727405 ↗
• InjurySep 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY FUSION (ACDF) PROCEDURE AT THE C4-C7 LEVELS ON (B)(6) 2018. THE PATIENT WAS IMPLANTED WITH ONE (1) VECTRA 51MM PLATE, THREE (3) UNKNOWN 7MM SPACERS WITH CENTRAL LUMEN, AND ONE (1) 1CC VIVIGEN POUCH. POSTOPERATIVELY, ON (B)(6) 2018, THE PATIENT PRESENTED WITH DIFFICULTY SWALLOWING, AND ON (B)(6) 2018, THE PATIENT PRESENTED WITH SWELLING IN THE NECK. AS OF (B)(6) 2018, BOTH EVENTS HAVE RESOLVED. CONCOMITANT DEVICES: VIVIGEN (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1CC); ACF SPACER-LORDOTIC 7MM (PART: 017207, LOT: 00514025521027, QUANTITY: 1); ACF SPACER-LORDOTIC 7MM (PART: 017207, LOT: 00514025521028, QUANTITY: 1); ACF SPACER-LORDOTIC 7MM (PART: 017207, LOT: 00616061301055, QUANTITY: 1). THIS REPORT IS FOR A TITANIUM (TI) VECTRA(TM) PLATE 3 LEVEL/51MM. THIS IS REPORT 1 OF 2 FOR (B)(4) AND WILL CAPTURE THE SWELLING IN THE NECK. THE PATIENT¿S DIFFICULTY SWALLOWING IS CAPTURED IN (B)(4).

  Patient problems: Swelling

  MAUDE report 7890236 ↗
• InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY FUSION (ACDF) PROCEDURE AT THE C4-C7 LEVELS ON (B)(6) 2018. THE PATIENT WAS IMPLANTED WITH ONE (1) VECTRA 51 MM PLATE, THREE (3) 7 MM SPACERS WITH CENTRAL LUMEN, AND ONE (1) 1 CC VIVIGEN POUCH. POSTOPERATIVELY, ON (B)(6) 2018 THE PATIENT PRESENTED WITH DIFFICULTY SWALLOWING. THE PATIENT WAS TREATED WITH A MEDROL DOSE PACK, AND THE OUTCOME WAS REPORTED AS RECOVERED/RESOLVED WITH NO RESIDUAL EFFECTS. ON (B)(6) 2018, THE PATIENT PRESENTED WITH SWELLING IN THE NECK. CONCOMITANT DEVICES REPORTED: BIOLOGIC TISSUE MATRIX: VIVIGEN (PART BL-1500-001, LOT 1811149-8027, QUANTITY 1 CC CELL BONE); 7 MM ACF SPACER (PART 017207, LOT 00514025521027, QUANTITY 1); 7 MM ACF SPACER (PART 017207, LOT 00514025521028, QUANTITY 1); 7 MM ACF SPACER (PART 017207, LOT 00616061301055, QUANTITY 1) THIS REPORT IS TO CAPTURE THE DIFFICULTY SWALLOWING. THE SWELLING IN THE NECK WILL BE CAPTURED ON RELATED (B)(4). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 7863927 ↗

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-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-
• 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