PGIRecalls & reported problems across all models

We found 3 models of PGI by Nuvasive, Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

PGI recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 29, 2021Open, Classified

   The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.

   Z-0319-2022 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗

PGI models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PGI 1008947

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 recall0 reports
• PGI 1008948

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 recall0 reports
• PGI 1008949

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 recall0 reports

Other Nuvasive, Inc. products

• ReLine129 models · 451 reports
• MAGEC4 models · 77 reports · 1 recall
• CoRoent64 models · 102 reports
• Simplify Cervical Artificial Disc14 models · 48 reports · 1 recall
• Modulus41 models · 98 reports
• X-CORE29 models · 35 reports · 1 recall
• XLIF9 models · 53 reports
• MaXcess12 models · 52 reports