Novel 64813-011Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844856019324), received between Sep 7, 2018 and Sep 7, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

1 other recall cover devices cleared under the same FDA submission (K080699); 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.

• InjurySep 7, 2018Migration or Expulsion of Device; Unintended Movement

  THE NOVEL PEEK SPACER WAS IMPLANTED ON (B)(6) 2018 DURING A PLIF CASE AT L2/3/4/5. AFTER THE CASE, IMAGES SHOW ALIGNMENT WAS GOOD. SLIGHT MOVEMENT OF THE CAGE WAS OBSERVED SEVERAL DAYS LATER. IT WAS GRADUALLY SLIDING BACK. FINALLY, IT POPPED OUT OF THE DISK SPACE AND MIGRATED INTO THE VERTEBRAL CANAL. THE PATIENT BEGAN TO ENCOUNTER SOME PAIN. ON (B)(6) 2018 REVISION SURGERY SUCCESSFULLY REMOVED THE PEEK CAGE FROM THE PATIENT.

  Patient problems: Pain

  MAUDE report 7854879 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080699. One submission often covers many models, so check the product and lot details in each record.

• Z-0190-2010 · May 13, 2009 · Terminated
  Alphatec Spine, Inc., NOVEL SPINAL SPACER SYSTEM, Part Number(s): 64817-010, 64817-012, 64817-013, 64817-014, 64817-107, 64113-012, 64113-010, 64765-109, 64733-124. Spinal fixat