VECTRA 04.613.132Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034737140), received between Dec 12, 2017 and Sep 11, 2018 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE USING VIVIGEN CELLULAR BONE MATRIX AT THE C5-C7 LEVELS ON (B)(6) 2017, WHERE THE PATIENT WAS IMPLANTED WITH A VECTRA PLATE, TWO SPACERS WITH CENTRAL LUMEN, A VIVIGEN POUCH AND A DISTRACTOR PIN. POST-OPERATIVELY, ON (B)(6) 2018, THE PATIENT HAD A FALL IN SHOWER THAT RESULTED IN HEADACHE, HIP PAIN, AND SMALL LACERATION. ON (B)(6) 2018, THE PATIENT PRESENTED AGAIN WITH HIP PAIN. CONCOMITANT DEVICE REPORTED: UNK - BIOLOGIC TISSUE MATRIX: VIVIGEN (PART # UNKNOWN, LOT UNKNOWN, QUANTITY 1); DISTRACTOR PIN 12MM (PART # 02.600.022, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TI VECTRA(TM) PLATE 2 LEVEL/32MM. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 7864414 ↗
• InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED ADDITIONAL ADVERSE EVENT INFORMATION REPORTED. EVENT DATE (ONSET): (B)(6) 2017. ALERT DATE: 26-FEB-2019. PROCEDURE: TWO OR THREE LEVEL ACDF USING VIVIGEN CELLULAR BONE MATRIX DATE OF PROCEDURE: (B)(6) 2017 EVENT DESCRIPTION: DIVERTICULITIS OF COLON (ACUTE). PATIENT DETAILS: HEIGHT: 64 IN. ADDITIONAL PATIENT DETAILS: SITE AWARENESS DATE: 26 SEP 2017. DATE OF EVALUATION: 26 SEP 2017. NEW EVENT. HOSPITALIZATION (INITIAL OR PROLONGED): YES. LEVELS TREATED: C2-C3: NO. C3-C4: NO. C4-C5: NO. C5-C6: NO. C6-C7: NO. DATE OF CERVICAL SPINE ADDITIONAL SURGERY: BLANK COMPONENTS USED IN ADDITIONAL CERVICAL SPINE SURGERY: SCREWS: NO. PLATES: NO. SPACER: NO. OTHER COMPONENT: NO. OTHER TREATMENT: YES. OTHER TREATMENT, SPECIFY: CIPRO AND FLAGYL. OUTCOME: RECOVERED/RESOLVED WITH NO RESIDUAL EFFECTS DATE OF RESOLUTION OR DEATH: (B)(6) 2017. PRODUCT DETAILS: LOGLINE: 1, COMPONENT: PLATE IMPLANTED. CATALOG NUMBER: 04.613.132. LOT NUMBER ID: N/A. UNIQUE DEVICE IDENTIFIER: VECTRA PLATE. LOGLINE: 2, COMPONENT: SPACER WITH CENTRAL LUMEN. CATALOG NUMBER: 08.843.008. LOT NUMBER ID: N/A. UNIQUE DEVICE IDENTIFIER: ACIS SPACER. LOGLINE: 3, COMPONENT: VIVIGEN POUCH. CATALOG NUMBER: BL-1500-001. LOT NUMBER

  Patient problems: No Code Available; Pain

  MAUDE report 7108178 ↗

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