Novel Spinal Spacer System 64813-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844856019294), received between Aug 26, 2019 and Aug 26, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K050553); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryAug 26, 2019Break

  DURING A TILF OF THE L5/S A NOVEL PEEK CAGE BROKE WHILE INSERTING. BECAUSE THE INTERBODY OF THE PATIENT WAS NARROW, THE SURGEON HIT THE CAGE WITH THE HAMMER A FEW TIMES AND FOUND THE CAGE HAD BROKEN INTO THE PIECES. THE INCIDENT CAUSED ONE HOUR DELAY OF THE CASE. THE SURGEON COULD NOT RECOVER ALL THE PIECES OF THE BROKEN CAGE, SO SOME FRAGMENTS REMAIN WITHIN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8932369 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050553. One submission often covers many models, so check the product and lot details in each record.

• Z-0508-2009 · Aug 16, 2007 · Terminated
  Novel PEEK VBR XS 16-22 MM, S-5, 26MM, Part Numbers : 64753-126. Indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged