Actifuse Shape 506005078068Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05060050780685), received between Aug 7, 2020 and Aug 7, 2020 — classified as 1 injury.

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

Recent adverse event reports

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

• InjuryAug 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A STUDY WAS PERFORMED IN WHICH A PATIENT UNDERWENT A SPINAL SURGICAL PROCEDURE WITH PLACEMENT OF ACTIFUSE SHAPE 1-2MM IN THE POSTEROLATERAL LUMBAR REGION. IT WAS REPORTED THE PATIENT WAS DISCHARGED THREE DAYS AFTER THE PROCEDURE WITH NO POST-OPERATIVE COMPLICATIONS REPORTED. APPROXIMATELY THREE AND A HALF MONTHS POST-OP, THE PATIENT UNDERWENT MAGNETIC RESONANCE IMAGING WHICH REVEALED A LEFT FACET CYST. APPROXIMATELY FOUR MONTHS AFTER THE MRI, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXCISE THE CYST. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Cyst(s)

  MAUDE report 10380054 ↗