RELIANCE AL 48361234Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07613327269147), received between Feb 17, 2016 and Sep 21, 2018 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Break” (21 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT THE TRIAL INSERTER BROKE INSIDE THE TRIAL UPON IMPACTION. THE TIP OF THE INSERTER REMAINED INSIDE THE TRIAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7898539 ↗
• MalfunctionAug 29, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT THE THREADED PORTION OF THE SHAFT BROKE OFF WHILE IN PATIENT. TRIAL WAS REMOVED USING A KOCHER. A SURGICAL DELAY OF APPROXIMATELY 1 MINUTE WAS REPORTED. SURGERY WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCES REPORTED.

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

  MAUDE report 7831422 ↗
• MalfunctionJul 2, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT DURING AN L4-5 SURGERY, THE TIP OF THE TRIAL HANDLE BROKE OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

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

  MAUDE report 7656594 ↗
• MalfunctionJun 13, 2018Break; Fracture; Fracture

  IT IS REPORTED THAT A TRIAL INSERTER TIP BROKE UPON IMPACTION. NO DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT IS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7598024 ↗
• MalfunctionJun 1, 2018Break; Entrapment of Device; Fracture; Fracture

  IT WAS REPORTED THAT THE SURGEON REMOVED THE TRIAL HANDLE TO TAKE A COUPLE OF X-RAYS WITH THE TRIAL IN THE DISC SPACE. UPON REINSERTING/RETHREADING THE TRIAL INSERTER INTO THE TRIAL, THE THREADED TIP BROKE OFF INSIDE OF THE TRIAL. THE SURGEON USED A CURETTE FROM THE HOSPITAL TO REMOVE THE TRIAL FROM THE DISC SPACE AND THEN USED A SECOND TRIAL INSERTER TO TRIAL DIFFERENT SIZES FOR THE REST OF THE CASE. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7560736 ↗
• MalfunctionMar 21, 2018Fracture; Break; Detachment Of Device Component; Fracture

  IT WAS REPORTED THAT A PIECE AT THE TIP OF THE TRIAL INSERTER BROKE OFF INSIDE THE TRIAL, WHILE TESTING FOR SIZE IN THE PATIENT. A BACKUP INSTRUMENTT WAS USED TO REMOVE THE TRIAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7356727 ↗
• MalfunctionDec 28, 2017Break; Detachment Of Device Component; Fracture; Fracture

  IT WAS REPORTED THAT; TRIAL THREADS BROKE OFF IN TRIAL.

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

  MAUDE report 7150786 ↗
• MalfunctionJul 7, 2017Fracture; Material Integrity Problem; Break; Detachment Of Device Component; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; WHILE I WAS PUTTING SETS BACK TOGETHER TO GO BACK UP FOR A CASE, I NOTICED THAT THE TRIAL HANDLE WAS MISSING ITS TIP AND THERE WAS ALSO A SOLID TRIAL WITH A TIP BROKEN OFF IN IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6694608 ↗
• MalfunctionJun 29, 2017Fracture; Break; Detachment Of Device Component; Fracture

  IT WAS REPORTED THAT;THE TIP OF TWO TRIAL HANDLES BROKE OFF INTO THE TRIALS IN THE CASE. ALL BROKEN FRAGMENTS. REPLACEMENT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6676665 ↗
• MalfunctionJun 29, 2017Fracture; Break; Fracture

  IT WAS REPORTED THAT; THE TIP OF TWO TRIAL HANDLES BROKE OFF INTO THE TRIALS IN THE CASE. ALL BROKEN FRAGMENTS. REPLACEMENT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6676663 ↗
• MalfunctionJun 26, 2017Fracture; Break; Fracture

  IT WAS REPORTED THAT; IN SURGICAL PROCEDURE SCHEDULED FOR MONDAY (B)(6), THE BREAKDOWN OF THE END PART OF OCCURRED, THE THREADED END PART REMAINED INSIDE THE TRIAL METAL CAGE , THE METAL CAGE REMAINED INSIDE THE INTERSOMAL SPACE IN THE PATIENT, A MECHANICAL GRIPPER WAS USED FOR ITS REMOVAL, A TIME OF 15 MINUTES OF DELAY WITH DIFFICULT REMOVAL. WITHOUT USING THE TRIAL, THE PHYSICIAN HAD TO USE THE "CAGE " METAL TRIAL CAGES PRESENT IN THE HOSPITAL . DISK SPACE HAS BEEN EMPTIED AND WORKED WITH TOOLS DEDICATED TO PREPARATION OF THE DISK. THE TRIAL CAGE IS PLACED ON THE INSERT. THE INSERTION WAS BEATEN WITH A HAMMER TO PLACE THE CAGE INSIDE THE SPACE. THE INSERTION BROKE. THE TRIAL CAGE WAS REMOVED WITH MECHANICAL CLAMP. THERE WERE NO CONSEQUENCES FOR THE PATIENT, BUT THEY LOST 15 MINUTES FOR REMOVAL WITH A TOOL NOT DEDICATED TO THE FRONT SURGERY NEAR VASES IN A COMPLEX ANATOMY.

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

  MAUDE report 6668007 ↗
• MalfunctionApr 18, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT THE TRIAL BROKE OFF FROM THE TRIAL INSERTER WHILE IN THE DISC SPACE. TRIAL WAS ABLE TO BE REMOVED AND CASE WAS FINISHED SUCCESSFULLY WITH NO COMPLICATIONS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6501561 ↗
• MalfunctionDec 1, 2016Fracture; Break; Fracture

  IT WAS REPORTED THAT DUE TO SEVERE SACRAL TILT, SURGEON STRUGGLED TRIALING AT L5-S1. TWO TRIAL TIPS WERE BROKEN AND ONE TIP REMAINED INSIDE THE TRIAL ITSELF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6138236 ↗
• MalfunctionDec 1, 2016Fracture; Break; Fracture

  IT WAS REPORTED THAT DUE TO SEVERE SACRAL TILT, SURGEON STRUGGLED TRIALING AT L5-S1. TWO TRIAL TIPS WERE BROKEN AND ONE TIP REMAINED INSIDE THE TRIAL ITSELF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6138221 ↗
• MalfunctionNov 21, 2016Fracture; Break; Fracture

  IT WAS REPORTED THAT THE TRIAL (26X32, 11 8 DEGREES) BROKE OFF OF TRIAL INSERTED WITH THREADED PORTION OF TRIAL INSERTER STUCK IN TRIAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6118673 ↗
• MalfunctionSep 26, 2016Fracture; Break; Fracture; Device Slipped; Device Operates Differently Than Expected; Device Handling Problem

  IT WAS REPORTED THAT: THE SURGEON USED A MALLET TO PUSH THE TRIAL IN. UPON TRYING TO REMOVE THE TRIAL WITH THE SLAP HAMMER THE TRIAL INSERTER BROKE, LEAVING THE THREADED PORTION INSIDE THE TRIAL AND THE TRIAL IN THE PATIENT. IT WAS REMOVED WITH A KOCHER AND CAUSED A 5 MINUTE SURGERY DELAY; THE ANCHOR ATTACHED TO THE WHITE CARTRIDGE WAS LOADED BACKWARDS. AS THE SURGEON WENT TO PUT THE ANCHOR DOWN THE SLOT HE NOTICE THE POINTED TIP WAS NOT POINTING OUT. THE SCRUB TECH REMOVED THE ANCHOR AND RELOADED IT PROPERLY. THIS RESULTED IN A 2 MINUTE SURGERY DELAY; ONE OF THE SCREWS ON THE RETRACTOR RING CAME OUT. IT WAS ABLE TO BE PUT IN AND THE RING WAS ABLE TO BE LOCKED DOWN. THE LOCKING NUT ON ONE OF THE RETRACTOR ARMS IS STUCK IN THE LOCKED POSITION. IT IS UNABLE TO BE LOOSENED TO REMOVE THE RING. THE RING WAS DISASSEMBLED TO REMOVE IT FROM THE ARM. THIS DID NOT CAUSE A DELAY IN THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5978438 ↗
• MalfunctionSep 7, 2016Break; Detachment Of Device Component; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT THE DISTAL TIP OF TRIAL INSERTER BROKE OFF IN TRIAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5934030 ↗
• MalfunctionJun 15, 2016Break; Fracture; Fracture

  IT WAS REPORTED THAT THE SURGEON WAS INSERTING A TRIAL WHEN THE TRIAL TIP BROKE IN THE TRIAL. HE USED A RONGEUR TO REMOVE THE TRIAL. THERE WAS NO SURGICAL DELAY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5726078 ↗
• MalfunctionFeb 26, 2016Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT TWO TRIALS AND A TRIAL INSERTER WERE BROKEN DURING CASE. THE TRIALS WILL BE RETURNED HOWEVER THE TRIAL HANDLE WAS DISCARDED BY THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5463466 ↗
• MalfunctionFeb 17, 2016Fracture; Material Integrity Problem; Break; Detachment Of Device Component; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; DR. (B)(6) WAS INSERTING A TRIAL WHEN THE TIP BROKE OFF FROM THE TRIAL HANDLE INTO THE TRIAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5442783 ↗
• MalfunctionFeb 17, 2016Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT UPON HAMMERING AN A TRIAL INTO THE DISC SPACE, THE INSERTER THREADED TIP BROKE AND LEFT THE TRIAL DISENGAGED IN THE DISC SPACE REP FOUND THE TIP OF THE INSERTER IN THE TRIAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5442782 ↗