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VuePoint 8970000P3Recalls & reported problems

Nuvasive, Inc. · VuePoint II Set Screw, Tulip&LaminarHook · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517829054), received between Sep 10, 2020 and Sep 10, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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

  • Loosening of Implant Not Related to Bone-Ingrowth1

Patient problems

  • Failure of Implant1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 10, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    THE PATIENT UNDERWENT A SPINAL PROCEDURE AT C3/T1 LEVELS ON (B)(6) 2020. IT WAS DISCOVERED DURING A ROUTINE FOLLOW UP X-RAY THAT A SET SCREW CAME OFF AT LEFT C3 LEVEL. A REVISION PROCEDURE TO REPLACE THE SET SCREW WITH NEW ONE WAS PERFORMED ON (B)(6) 2020.

    Patient problems: Failure of Implant

    MAUDE report 10519087 ↗

Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices

All APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices →

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