RADIUS 486619100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327276053), received between Jul 9, 2016 and May 23, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT THE RADIUS HEIGHT ADJUSTER WAS DISCOVERED BROKEN POST SURGERY. THE INSTRUMENT WAS USED DURING SURGERY TO REMOVE A RADIUS RAPID SCREW. THE INSTRUMENT WAS ABLE TO SUCCESSFULLY REMOVE THE SCREW. IT IS UNKNOWN IF THE ADJUSTER BROKE DURING THE SURGERY. IT IS UNKNOWN IF ANY FRAGMENTS ENTERED THE PATIENT CAVITY. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7538601 ↗
• MalfunctionJan 3, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT; HEIGHT ADJUSTER TIP BROKE WHILE ADJUSTING SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7160565 ↗
• MalfunctionDec 27, 2017Break

  IT WAS REPORTED THAT; ADJUSTMENT DRIVER TIP BROKE. SALES REP HAD ANOTHER, NO ADVERSE CONSEQUENCES OR SURGICAL DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7147341 ↗
• MalfunctionSep 6, 2017Fracture; Break; Fracture

  IT WAS REPORTED THAT; UPON REMOVING A PREVIOUSLY IMPLANTED SCREW FROM A PATIENT'S SPINE DUE TO ADJACENT LEVEL DISEASE, A PIECE OF THE MULTI-ANGLE ADJUSTMENT TOOL TIP BROKE OFF. THE INSTRUMENT WAS REMOVED, AND THE BROKEN PIECE WAS FOUND IMMEDIATELY AND REMOVED FROM THE WOUND. THE SURGEON USED THE MULTI ANGLE SCREWDRIVER TO REMOVE THE REST OF THE REMAINING SCREWS.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 6846172 ↗
• MalfunctionJul 9, 2016Break; Detachment Of Device Component; Fracture; Fracture

  IT WAS REPORTED THAT; SURGEON WAS REMOVING A PEDICLE SCREW AND THE TIP OF THE DRIVER BROKE OFF DURING A REVISION UPDATE (B)(6) 2016: REVISION SURGERY WAS TO REMOVE THE SCREWS AT L4-S. THERE WAS A BROKEN SCREW AT S1. THEN TLIF L3-L4. THE. REINSERT SCREWS FROM L3-S1 USING COMPETITOR'S SCREWS.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 5780594 ↗