Arsenal 48007-55-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844856073432), received between Jun 6, 2018 and Jun 24, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2019Break

  BOTH RODS HAD BEEN IMPLANTED AND THE FINAL SET SCREW ON THE PROXIMAL LEFT SIDE T4 INSERTED. THE SURGEON NOTICED THAT ADDITIONAL SAGITTAL CORRECTION WAS REQUIRED. WHILE ADDING MORE KYPHOSIS, THE ROD SNAPPED AND BROKE AROUND THE C5. THE ROD AND DETACHED FRAGMENTS WERE COMPLETELY REMOVED FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8727765 ↗
• InjuryJun 6, 2018Bent; Break; Fracture

  DURING A VCR (VERTEBRAL COLUMN RESECTION), A COCR ROD FRACTURED AND BROKE. THE COCR ROD WAS BENT WITH A FRENCH BENDER ON THE BACK TABLE WITH AN APPROXIMATE 90 DEGREE BEND OVER THE AREA OF THE VCR. ONCE PLACING THE COCR ROD AND SECURING IT INTO THE SCREWS, IN-SITU BENDERS WERE USED TO GET ADDITIONAL CORRECTION THROUGH THE VCR SECTION WHEN THE COCR ROD FRACTURED. THE SURGEON INDICATED THAT VERY LITTLE ADDITIONAL FORCE WAS APPLIED DURING THE IN-SITU BEND. THE EVENT CAUSED OVER A 30 MINUTE DELAY IN THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7574169 ↗