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VuePoint 8970000Recalls & reported problems

Nuvasive, Inc. · VP II Set Screw, Tulip and Laminar Hook · Class 2 · Implant

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887517397133), received between Dec 8, 2016 and Aug 19, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Detachment Of Device Component2
  • Migration or Expulsion of Device2

Patient problems

  • Failure of Implant3
  • No Known Impact Or Consequence To Patient2
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 19, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

    ON (B)(6)2021 A PATIENT UNDERWENT A CERVICAL POSTERIOR FIXATION PROCEDURE FROM O-C2. THE SURGERY WAS COMPLETED WITHOUT ISSUE. ON (B)(6)2022 IT WAS DISCOVERED THE RIGHT SCREW AT C2 HAD LOOSENED AND THE SET SCREW IN THE LEFT C2 HAD BACKED OUT. THE PATIENT WAS ASYMPTOMATIC AND THEIR POST OP ACTIVITY LEVELS COULD NOT BE CONFIRMED. ON (B)(6)2022 A REVISION SURGERY OCCURRED WHERE THE RIGHT LOOSENED PEDICLE SCREW AND THE BACKED OUT SET SCREW WHERE REPLACED. THE PATIENT CONTINUES TO REMAIN ASYMPTOMATIC POST REVISION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15261820 ↗
  • MalfunctionNov 30, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

    ON (B)(6) 2018 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE AT C2-C6 WITHOUT ANY REPORTED ISSUES. ON A LATER DATE POST-OPERATIVE RADIOGRAPHS REVEALED THREE BACKED OUT LOCK SCREWS AT C2-C4 LEVELS. ON (B)(6) 2018 A REVISION PROCEDURE TOOK PLACE TO REMOVE AND REPLACE THE THREE LOCK SCREWS WITHOUT A REPORTED ISSUE.

    Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

    MAUDE report 8120566 ↗
  • MalfunctionApr 2, 2017Detachment Of Device Component; Detachment Of Device Component

    ON (B)(6) 2017 A SIX-LEVEL POSTERIOR CERVICAL FIXATION WAS PERFORMED. ON (B)(6) 2017 IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF MULTIPLE LOCK SCREWS. NO INJURY WAS REPORTED.

    Patient problems: Failure of Implant

    MAUDE report 6452386 ↗
  • MalfunctionDec 8, 2016Detachment Of Device Component; Detachment Of Device Component

    ON (B)(6) 2016 A (B)(6) MALE PATIENT UNDERWENT A PROCEDURE AT C3-T1. AT 12 WEEK FOLLOW UP THE PATIENT REPORTED A "CLICKING" SOUND THAT WAS VERIFIED BY RADIOGRAPH AS A POST-OPERATIVE LOCK SCREW LOOSENING AT THE T1 DISC LEVEL. THERE ARE NO PLANS FOR REVISION. NO PATIENT INJURY REPORTED.

    Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

    MAUDE report 6156408 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.