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Affix 7577035Recalls & reported problems

Nuvasive, Inc. · Affix II Plate, 35mm · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517062345), received between Oct 25, 2017 and Oct 25, 2017 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1
  • Contamination1

Patient problems

  • Patient Problem/Medical Problem1
  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryOct 25, 2017Contamination; Adverse Event Without Identified Device or Use Problem; Contamination; Adverse Event Without Identified Device or Use Problem

    ON (B)(6) 2016 A PATIENT UNDERWENT AN INTERLAMINAR LUMBAR INSTRUMENTED FUSION PROCEDURE AT L5-S1 LEVELS WITH NO KNOWN ISSUES. DURING A FOLLOW UP IT WAS OBSERVED THAT THE INCISION SITE WAS NOT HEALING. ON (B)(6) 2017 A REVISION PROCEDURE TOOK PLACE TO REMOVE THE IMPLANTS WITHOUT REPORTED ISSUE.

    Patient problems: Patient Problem/Medical Problem; Unspecified Infection

    MAUDE report 6977789 ↗

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.