Novel 64918Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844856041271), received between Nov 29, 2016 and Nov 29, 2016 — 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 (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 16, 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.

• InjuryNov 29, 2016Break

  THE THREADED PART OF THE INSERTER THAT THREADS INTO THE PEEK IMPLANT SHEARED OFF INSIDE THE IMPLANT DURING INSERTION. WHILE TRYING TO RETRIEVE THE IMPLANT, PART OF THE IMPLANT RETRIEVER BROKE INSIDE OF THE PATIENT. THERE WAS ABOUT A 30 MINUTE DELAY IN THE CASE FROM THE TIME THE FIRST INSTRUMENT BROKE, TO THE TIME THE CAGE WAS SUCCESSFULLY PLACED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6132847 ↗

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