T2 STRATOSPHERE™ Expandable Corpectomy System 4360113 (UDI 00643169709447)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169709447), received between Nov 16, 2021 and Sep 25, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Mechanical Problem

  Information was received from user facility via a manufacturer representative regarding a device used for Corpectomy at level C6. It was reported that the locking ring was difficult to move and the inserter was also difficult to remove when testing fit and function when loading and removing the implant. There was no patient involvement reported. There were no further complications reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893798 ↗
• MalfunctionMay 26, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE PROVISIONAL LOCKING MECHANISM WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273601 ↗
• MalfunctionMay 18, 2026Break; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM THE USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER WAS BROUGHT TO THE FACILITY FOR PRE OPERATIVE DECONTAMINATION AND AFTER DECONTAMINATING THE PRIMARY STRUCTURAL SECURITY SCREW WAS FOUND TO BE MISSING, LEAVING THE INSERTER USELESS. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED AS THE INSERTER HAS BEEN USED BEFORE IN CASES WITHOUT ANY MALFUNCTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25197337 ↗
• MalfunctionApr 7, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING MULTIPLE INSTRUMENTS. IT WAS REPORTED THAT DURING FIELD CONTACT, THE FOLLOWING DEVICE-RELATED ISSUES AND MALFUNCTIONS WERE IDENTIFIED: THE SLEEVE 7967028 INSERTER WOULD NOT ATTACH WITH TRIAL, THE SHAFT 2161001 OLIF25 INTERBODY THREADED HAD A TIP THAT BROKE OFF, THE INSERTER 4360113 13MM INSERTER CASE WAS NOT ATTACHING, AND THE DRIVER 6630904 T8/T10 DRIVER WAS STRIPPED. TIP BROKE OFF FOR INSERTER 6279002 PSR ENDCAP THREADED. DRIVER 7080907 2.5 HEX SCREWDRIVER (QTY-2) WERE STRIPPED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24804952 ↗
• MalfunctionMar 25, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER EXPERIENCED ISSUES INCLUDING A SCREW LOST FROM THE INSERTER, OTHER SCREWS BEING LOOSE BUT REMAINING IN THE INSTRUMENT, AND SCREWS FALLING OUT DURING STERILIZATION. THERE WAS NO PATIENT. NO FURTHER COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24684097 ↗
• MalfunctionMar 12, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING SERVICING. IT WAS REPORTED THAT THE INSERTER WAS BROKEN. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24578798 ↗
• MalfunctionJan 8, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, THE LOCKING RING WAS GRINDING AND HARD TO TURN, RESULTING IN THE IMPLANT NOT PRIMARILY LOCKING. THE LOCKING RING ON THIS INSTRUMENT FROM THIS SET IS INCONSISTENT. PROCEDURE PERFORMED WAS CORPECTOMY. THE ISSUE WAS IDENTIFIED INTRA OPERATIVELY, ON THE SIDE TABLE. THE INSTRUMENT WAS USED SUCCESSFULLY DURING PREVIOUS CASES. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24002252 ↗
• MalfunctionDec 23, 2022Material Twisted/Bent; Mechanics Altered; Material Twisted/Bent; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING AN INSERTER USED IN T12 VERTEBRAL COLUM RESECTION/T2-ILIUM PSF THERAPY FOR SCOLIOSIS. IT WAS REPORTED THAT THE INSERTER WOULD NOT RELEASE FROM THE CORPECTOMY CAGE WHILE INSIDE THE PATIENT. THE DOCTOR STRUGGLED TO REMOVE THE INSERTER AND TWISTED TO REMOVE IT, CAUSING THE DISTAL TIP TO BEND. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16041839 ↗
• MalfunctionJul 5, 2022Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE IN A PATIENT DIAGNOSED WITH T5 TUMOR. IT WAS REPORTED THAT WHEN THE IMPLANT WAS LOADED ON THE INSERTER AND IT WAS EXPANDED IN THE SPACE, THE T HANDLE MAKE A CRANKING SOUND. THE IMPLANT WOULD NOT COME OFF OF THE INSERTER EASILY AND THE CRACKING SOUND OCCURRED WHEN THE HCP TRIED AGAIN. THE IMPLANT WAS TAKEN OUT, INSPECTED IT WITH THE SURGEON AND THEN THE DOCTOR PROCEEDED TO USE THE NAVIGATED INSERTER. THERE WAS NO ISSUE WITH THE IMPLANT. THE INSERTER WAS BEING USED ON THE PATIENT WHEN THE EVENT OCCURRED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14912001 ↗
• MalfunctionFeb 14, 2022Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL CORPECTOMY DUE TO UNKNOWN INDICATION. IT WAS REPORTED THAT THE LOCKING SCREWDRIVER WOULD NOT ENGAGE IN THE SCREW ON THE INSERTER. THEY HAD TO PROVISIONALLY TIGHTEN, REMOVE THE INSERTER, AND LOCK ONCE INSERTER WAS REMOVED. PRODUCT CAME IN PATIENT CONTACT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13521661 ↗
• MalfunctionFeb 8, 2022Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS- STENOSIS/TRAUMA INVOLVED IN THE ACDF/CORPECTOMY/STRATOSPHERE CAGE PROCEDURE. LEVELS IMPLANTED/TREATED C4-6 IT WAS REPORTED THAT INTRA-OPERATIVELY, IMPLANT WOULD NOT PROPERLY EXPAND AND MADE A RATCHETING NOISE. TEETH ON EXPANSION PORTION OF THE CAGE APPEAR TO BE DAMAGED AND RENDERED THE IMPLANT USE. IMPLANT WAS INSERTED INTO THE PATIENT AND THEN REMOVED. SURGEON SELECTED A DIFFERENT IMPLANT TO COMPLETE THE CASE. IT WAS BELIEVED THAT THE INSERTER DID NOT FULLY ENGAGE THE IMPLANT BEFORE EXPANSION. THERE WERE NO PATIENT SYMPTOMS REPORTED AS A RESULT OF THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. PATIENT IS ALIVE AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13491927 ↗
• MalfunctionDec 14, 2021Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ACCF THERAPY. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS CENTRAL STENOSIS. IT WAS REPORTED THAT BOTH DRIVERS FAILED TO LOCK THE CAGE WITH THE INSERTER ON. THE INSERTER ITSELF FAILED TO LOCK THE CAGE IN PLACE WITH THE INNER LOCKING RING AND JUST SPUN AND WOULD NOT ENGAGE. THE INNER SCREW DRIVER HOLE MAY ALSO APPEAR STRIPPED. ALL ITEMS CAME IN CONTACT WITH PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12995385 ↗
• MalfunctionNov 16, 2021Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING C 5-7 ACDF PROCEDURE IN A PATIENT DIAGNOSED WITH C6 CORPECTOMY FOR CERVICAL STENOSIS. IT WAS REPORTED THAT THE RING ON THE INSERTER WOULD NOT TIGHTEN THE SET SCREW AFTER INSERTION. THERE WERE NO ISSUES WITH THE IMPLANT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12825242 ↗