ARIA 48759701Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327272772), received between Apr 6, 2016 and Feb 24, 2018 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2018Fracture; Detachment Of Device Component; Component Falling; Fracture

  IT WAS REPORTED THAT UPON IMPACTING THE TRIAL HANDLE ASSEMBLY, DURING AN L2-L3 PROCEDURE, A PIECE OF METAL FELL OUT OF THE CONNECTION POINT AND THE CONNECTION WILL NO LONGER ACCEPT AN INSTRUMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND ALL FRAGMENTS WERE RETRIEVED. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7294476 ↗
• MalfunctionJan 26, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT THE QUICK RELEASE HANDLES BROKE DURING SURGERY. ALL THE BROKEN FRAGMENTS WERE RETRIEVED. NO ADVERSE HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7222729 ↗
• MalfunctionNov 22, 2017Break; Fracture; Fracture

  IT WAS REPORTED THAT; DURING A LATERAL CASE, TWO SEPARATE TRIAL/SHAVER HANDLES BROKE, HALF THE QUICK RELEASE MECHANISM FELL ONTO THE FIELD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7052171 ↗
• MalfunctionSep 26, 2017Break; Metal Shedding Debris; Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT; DURING INSERTION OF THE TRIAL WITH THE HANDLE, A PIECE OF METAL BREAK OFF OF IT. ISSUE OCCURED WHILE MALLETING THE HANDLE INTO THE DISC SPACE. THE DISC SPACE HAD BEEN CLEANED OUT AND THE DISC HAD ALREADY BEEN REMOVED. THE PATIENT HAD AVERAGE DISC SPACE NOTHING OUT OF THE ORDINARY. ISSUE OCCURED AT L3 L4. ALL BROKEN FRAGMENTS WERE RETRIEVED. NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY. BACK UP HANDLE WAS USED TO SUCCESSFULLY COMPLETE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6893407 ↗
• MalfunctionAug 22, 2017Material Integrity Problem; Break; Detachment Of Device Component; Component Falling; Material Integrity Problem

  IT WAS REPORTED THAT; TRIAL HANDLE TIP OF KNOB OR TRIAL HANDLE BROKE OFF DURING SURGERY. 2 TABS, ONE MAY HAVE ALREADY BEEN MISSING, OTHER MAY HAVE OFF. DURING SURGERY WHILE INSERTING THE TRIAL, THE SURGEON SOFTLY IMPACTED THE HANDLE AND THE TIP OF THE KNOB, WHERE THE HANDLE CONNECTS TO THE TRIAL, BROKE OFF. ONE TAB OF THE INSTRUMENT MAY HAVE ALREADY BEEN MISSING. THE OTHER TAB FELL OFF DURING THIS SURGERY AND WAS SUCCESSFULLY RETRIEVED. WHILE USING THE SECOND BACK UP HANDLE, WHEN THE HANDLE WAS TAKEN OFF TO TAKE AN X-RAY, METAL FRAGMENTS CAME OFF. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. SURGERY WAS SUCCESSFULLY COMPLETED WITH THE SECOND TRIAL HANDLE. BOTH INSTRUMENTS WERE PREVIOUSLY USED SUCCESSFULLY. REP HAD THE SET FOR 2 WEEKS AND IT WAS USED 3X SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6811844 ↗
• MalfunctionAug 22, 2017Adverse Event Without Identified Device or Use Problem; Break; Detachment Of Device Component; Component Falling; Material Fragmentation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT; TRIAL HANDLE TIP OF KNOB OR TRIAL HANDLE BROKE OFF DURING SURGERY. 2 TABS, ONE MAY HAVE ALREADY BEEN MISSING, OTHER MAY HAVE OFF. DURING SURGERY WHILE INSERTING THE TRIAL, THE SURGEON SOFTLY IMPACTED THE HANDLE AND THE TIP OF THE KNOB, WHERE THE HANDLE CONNECTS TO THE TRIAL, BROKE OFF. ONE TAB OF THE INSTRUMENT MAY HAVE ALREADY BEEN MISSING. THE OTHER TAB FELL OFF DURING THIS SURGERY AND WAS SUCCESSFULLY RETRIEVED. WHILE USING THE SECOND BACK UP HANDLE, WHEN THE HANDLE WAS TAKEN OFF TO TAKE AN X-RAY, METAL FRAGMENTS CAME OFF. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. SURGERY WAS SUCCESSFULLY COMPLETED WITH THE SECOND TRIAL HANDLE. BOTH INSTRUMENTS WERE PREVIOUSLY USED SUCCESSFULLY. REP HAD THE SET FOR 2 WEEKS AND IT WAS USED 3X SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6811843 ↗
• MalfunctionFeb 17, 2017Break; Detachment of Device or Device Component; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT; WHEN RELEASING HANDLE FROM TRIAL SHAFT A SMALL SHAVING OF METAL FELL OUT OF THE QUICK RELEASE MECHANISM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6340636 ↗
• MalfunctionNov 16, 2016Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT THE ROUND TRIAL HANDLE BROKE. ONE HALF OF THE COLLAR INSIDE BROKE OFF

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6107529 ↗
• MalfunctionOct 31, 2016Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT; THE COLLAR OF THE TRIAL HANDLE BROKE OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6067911 ↗
• MalfunctionApr 6, 2016Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT WHILE PULLING THE TRIAL HANDLE OUT THE DURING PROCEDURE, THE INNER LOCKING SLEEVE BROKE FROM THE TRIAL HANDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5552282 ↗