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VuePoint 8975430Recalls & reported problems

Nuvasive, Inc. · VuePoint® II Screw, 4.0x30mm MA · 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 00887517398383), received between Jan 8, 2021 and Jan 8, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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

  • Fracture1

Patient problems

  • Nonunion/Delayed-union Bone Fracture1

Recent adverse event reports

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

  • MalfunctionJan 8, 2021Fracture; Fracture

    ON (B)(6) 2018 A PATIENT UNDERWENT A SPINAL SURGERY AT C1-2. POST-OP ON AN UNKNOWN DATE, IT WAS DISCOVERED THAT FOUR IMPLANTED SCREWS FRACTURED. IT IS UNKNOWN IF THE PATIENT FOLLOWED POST OPERATIVE PHYSICAL RESTRICTIONS OR SUFFERED A FALL. ON (B)(6) 2020 A REVISION SURGERY WAS PERFORMED WHERE THE FRACTURED SCREWS WERE REPLACED WITH A COMPETITOR'S PRODUCT. IT WAS REPORTED THAT NON-UNION WAS OBSERVED.

    Patient problems: Nonunion/Delayed-union Bone Fracture

    MAUDE report 11140115 ↗

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.