NA 04.613.618Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034737836), received between Dec 1, 2017 and Dec 1, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 reports).

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.

• InjuryDec 1, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A PATIENT RECEIVED ONE (1) VECTRA PLATE AND SIX (6) SCREWS ON (B)(6) 2016. THE PATIENT EXPERIENCED TENDERNESS ON THE BACK OF HER NECK ON AN UNKNOWN DATE AND UPON FOLLOW-UP VISIT TO THE SURGEON, DISCOVERED THE SCREWS HAD BACKED OUT OF THE PLATE. THE PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017 FOR A HARDWARE REMOVAL. ALL IMPLANTED DEVICES WERE REMOVED INTACT AND NO ISSUES DURING REVISION. THE PATIENT DID NOT RECEIVE NEW IMPLANTS SINCE THE WOUND HAD HEALED. THE PROCEDURE WAS UNEVENTFUL WITH A STABLE PATIENT OUTCOME. NO SURGICAL TIME DELAY REPORTED. CONCOMITANT DEVICES REPORTED: VECTRA PLATE (PART# 04.613.136, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 4.0MM TI CERV SELF-RETAIN SCREW. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7074622 ↗
• InjuryDec 1, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A PATIENT RECEIVED ONE (1) VECTRA PLATE AND SIX (6) SCREWS ON (B)(6) 2016. THE PATIENT EXPERIENCED TENDERNESS ON THE BACK OF HER NECK ON AN UNKNOWN DATE AND UPON FOLLOW-UP VISIT TO THE SURGEON, DISCOVERED THE SCREWS HAD BACKED OUT OF THE PLATE. THE PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017 FOR A HARDWARE REMOVAL. ALL IMPLANTED DEVICES WERE REMOVED INTACT AND NO ISSUES DURING REVISION. THE PATIENT DID NOT RECEIVE NEW IMPLANTS SINCE THE WOUND HAD HEALED. THE PROCEDURE WAS UNEVENTFUL WITH A STABLE PATIENT OUTCOME. NO SURGICAL TIME DELAY REPORTED. CONCOMITANT DEVICES REPORTED: VECTRA PLATE (PART# 04.613.136, LOT# UNKNOWN, QUANTITY 1) . THIS REPORT IS FOR ONE (1) 4.0MM TI CERV SELF-RETAIN SCREW. THIS IS REPORT 4 OF 6 FOR (B)(4) .

  Patient problems: No Code Available

  MAUDE report 7074617 ↗