NA 04.613.616Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034737812), received between Dec 1, 2017 and Sep 26, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2023Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THAT DURING PLACEMENT OF THE VECTRA PLATE AND SCREWS, SURGEON FOUND THAT HE COULD NOT ADVANCE A 4.0 TI CERV SLF RTN SCR SLF-TPNG/VA 16MM SCREW BEYOND THE LOCKING MECHANISM ON THE PLATE. FLUOROSCOPY WAS USED, EVERYTHING LOOKED ACCEPTABLE FOR SCREW PLACEMENT AND ANGULATION. HE REMOVED THE SCREW, AND ATTEMPTED TO PLACE A SHORTER RESCUE SCREW 4.5 TI CERV SLF RTN SCR SLF-TPNG/VA 14MM IN ITS PLACE. THAT SCREW WOULD ALSO NOT PASS THE LOCKING MECHANISM. HE REMOVED THE RESCUE SCREW AND INSPECTED THE PLATE VISUALLY, AND SAW DIFFERENCES BETWEEN THAT SCREW HOLE AND THE OTHERS. HE ELECTED TO REMOVE THE ENTIRE CONSTRUCT AND START NEW. THIS LED TO MORE 4.0 TI CERV SLF RTN SCR SLF-TPNG/VA 16MM IMPLANTS BEING WASTED AND ARE PART OF THIS COMPLAINT. THE SURGERY WAS EASILY COMPLETED WITH A MINIMAL AMOUNT OF EXTRA TIME (UNDER 5 MINUTES). NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) 4.0 TI CERV SLF RTN SCR SLF-TPNG/VA 16MMTHIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821449 ↗
• MalfunctionSep 26, 2023Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6), 2023, THAT DURING PLACEMENT OF THE VECTRA PLATE AND SCREWS, SURGEON FOUND THAT HE COULD NOT ADVANCE A 4.0 TI CERV SLF RTN SCR SLF-TPNG/VA 16MM SCREW BEYOND THE LOCKING MECHANISM ON THE PLATE. FLUOROSCOPY WAS USED, EVERYTHING LOOKED ACCEPTABLE FOR SCREW PLACEMENT AND ANGULATION. HE REMOVED THE SCREW, AND ATTEMPTED TO PLACE A SHORTER RESCUE SCREW 4.5 TI CERV SLF RTN SCR SLF-TPNG/VA 14MM IN ITS PLACE. THAT SCREW WOULD ALSO NOT PASS THE LOCKING MECHANISM. HE REMOVED THE RESCUE SCREW AND INSPECTED THE PLATE VISUALLY, AND SAW DIFFERENCES BETWEEN THAT SCREW HOLE AND THE OTHERS. HE ELECTED TO REMOVE THE ENTIRE CONSTRUCT AND START NEW. THIS LED TO MORE 4.0 TI CERV SLF RTN SCR SLF-TPNG/VA 16MM IMPLANTS BEING WASTED AND ARE PART OF THIS COMPLAINT. THE SURGERY WAS EASILY COMPLETED WITH A MINIMAL AMOUNT OF EXTRA TIME (UNDER 5 MINUTES). NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) 4.0 TI CERV SLF RTN SCR SLF-TPNG/VA 16MM. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821448 ↗
• MalfunctionSep 26, 2023Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THAT DURING PLACEMENT OF THE VECTRA PLATE AND SCREWS, SURGEON FOUND THAT HE COULD NOT ADVANCE A 4.0 TI CERV SLF RTN SCR SLF-TPNG/VA 16MM SCREW BEYOND THE LOCKING MECHANISM ON THE PLATE. FLUOROSCOPY WAS USED, EVERYTHING LOOKED ACCEPTABLE FOR SCREW PLACEMENT AND ANGULATION. HE REMOVED THE SCREW, AND ATTEMPTED TO PLACE A SHORTER RESCUE SCREW 4.5 TI CERV SLF RTN SCR SLF-TPNG/VA 14MM IN ITS PLACE. THAT SCREW WOULD ALSO NOT PASS THE LOCKING MECHANISM. HE REMOVED THE RESCUE SCREW AND INSPECTED THE PLATE VISUALLY, AND SAW DIFFERENCES BETWEEN THAT SCREW HOLE AND THE OTHERS. HE ELECTED TO REMOVE THE ENTIRE CONSTRUCT AND START NEW. THIS LED TO MORE 4.0 TI CERV SLF RTN SCR SLF-TPNG/VA 16MM IMPLANTS BEING WASTED AND ARE PART OF THIS COMPLAINT. THE SURGERY WAS EASILY COMPLETED WITH A MINIMAL AMOUNT OF EXTRA TIME (UNDER 5 MINUTES). NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT OUTCOME THIS REPORT IS FOR ONE (1) 4.0 TI CERV SLF RTN SCR SLF-TPNG/VA 16MM THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821440 ↗
• 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 6 OF 6 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7074603 ↗
• 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 5 OF 6 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7074598 ↗