AVS 48329000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327267600), received between Jun 22, 2016 and Jul 10, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2017Fracture; Material Integrity Problem; Fracture; Component Missing; Material Integrity Problem

  IT WAS REPORTED THAT; WHEN REMOVING THE INSERTER, PHYSICIAN REALIZED THERE WAS NO RESISTANCE IN LOCKING MECHANISM. UPON FURTHER INSPECTION ON BACK TABLE, SCRUB TECH NOTICED THE SMALL RETAINING PIN WAS MISSING. MISSING PIN WAS FOUND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6699422 ↗
• MalfunctionMar 22, 2017Break; Fracture; Detachment of Device or Device Component; Fracture

  IT WAS REPORTED THAT THE INSERTER TIP BROKE OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6425302 ↗
• MalfunctionJun 22, 2016Device Operates Differently Than Expected; Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT; DURING THE SURGERY, THE SPACER INSERTER CAN'T CATCH THE CAGE. UPDATE (B)(6) 2016: SURGERY WAS COMPLETED WITH ANOTHER COMPETITOR'S INSTRUMENT. SURGEON NOT SATISFIED WITH POSITION OF THE CAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5743509 ↗