T2 STRATOSPHERE™ Expandable Corpectomy System 436013C (UDI 00643169663138)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169663138), received between Oct 1, 2019 and Sep 28, 2026 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Mechanical Problem

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a cage used for Spinal therapy. It was reported that the cage would not provisionally lock. There were no patient symptoms reported. There were no further complications reported regarding the event. Additional information received that the procedure involved was Anterior Cervical Discectomy and Fusion.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911737 ↗
• MalfunctionJun 3, 2025Mechanical Problem; Material Deformation; Mechanical Jam; Mechanical Problem; Material Deformation; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR T12 C ORPECTOMY. IT WAS REPORTED THAT THE DEVICE STUCK IN MID EXPANSION, WAS NOT EXPANDING AND COLLAPSING AS IT SHOULD AND STRIPPING WHILE ATTEMPTS WERE MADE TO EXPAND AND COLLAPSE THE CAGE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22129541 ↗
• InjuryApr 16, 2024Mechanical Problem; Mechanical Problem

  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 CERVICAL STENOSIS. IT WAS REPORTED THAT WHILE TRYING TO IMPLANT THIS CAGE AND EXPANDING IT TO THE PROPER HEIGHT IT WAS ATTEMPTED TO PROVISIONALLY TIGHTEN IT TO TAKE AN X-RAY TO CHECK PLACEMENT AND IT WOULD NOT STAY EXPANDED AND IT COLLAPSED. WHEN THE IMPLANT WAS CHECKED ON THE INSERTER AND ALL FELT AND LOOKED GOOD. SO IT WAS TRIED AGAIN AND THE SAME THING HAPPENED. SO ASSUMING EITHER THE SET SCREW OR THE CAGE ITSELF WAS BAD. THE 2ND ATTEMPT DID NOT WORK WORK SO STRUT GRAFT WAS USED INSTEAD. 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 19117016 ↗
• InjuryApr 16, 2024Mechanical Problem; Mechanical Problem

  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 CERVICAL STENOSIS. IT WAS REPORTED THAT WHILE TRYING TO IMPLANT THIS CAGE AND EXPANDING IT TO THE PROPER HEIGHT IT WAS ATTEMPTED TO PROVISIONALLY TIGHTEN IT TO TAKE AN X-RAY TO CHECK PLACEMENT AND IT WOULD NOT STAY EXPANDED AND IT COLLAPSED. WHEN THE IMPLANT WAS CHECKED ON THE INSERTER AND ALL FELT AND LOOKED GOOD. SO IT WAS TRIED AGAIN AND THE SAME THING HAPPENED. SO ASSUMING EITHER THE SET SCREW OR THE CAGE ITSELF WAS BAD. THE 2ND ATTEMPT DID NOT WORK WORK SO STRUT GRAFT WAS USED INSTEAD. 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 19117000 ↗
• MalfunctionFeb 1, 2023Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING CERVICAL CORPEC TOMY. IT WAS REPORTED THAT, CAGE HAS TROUBLE OPENING UP. THE IMPLANT WAS NOT OPENING ON THE INSERTER. SURGEON ENDED UP USING FIBULAR STRUT. THE C-SIZED CENTERPIECE CAME IN CONTACT WITH PATIENT BODY AND OTHER TWO CENTERPIECE DIDN'T CAME IN CONTACT. THE ISSUE WAS ID ENTIFIED WHEN TRYING TO OPEN IN THE PATIENT. ONLY ITEM 436013C 13MM C-SIZE WAS TRIED DURING THE SURGERY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16275810 ↗
• MalfunctionJun 28, 2022Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING SPINAL THERAPY DUE TO UNKNOWN INDICATION. IT WAS REPORTED THAT THE IMPLANT DOES NOT LOCK TO THE SIZE THAT THE PATIENT REQUIRES, A CAP IS PLACED ON IT TO INCREASE THE SIZE, THE IMPLANT REMAINS WITHOUT LOCKING. 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 14840537 ↗
• MalfunctionDec 21, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING CERVICAL CORPECTOMY SPINAL THERAPY AT C4. IT WAS REPORTED THAT TOOTH ON WORM GEAR INSIDE OF CENTERPIECE BROKE OFF DURING EXPANSION. PREVENTED SURGEON FROM USING THE CAGE TO DISTRACT UNDER LOAD. THE PART CAME IN CONTACT WITH THE PATIENT. 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 13050134 ↗
• MalfunctionAug 12, 2021Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH UNKNOWN INDICATION INVOLVED IN T7 CORPECTOMY. LEVELS IMPLANTED: T6-T8. IT WAS REPORTED THAT INTRA-OPERATIVELY, CAGE DID NOT EXPAND PROPERLY. PRODUCT WAS UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. THERE WAS DELAY IN OVERALL PROCEDURE TIME FOR 30 MINUTES. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. PATIENT IS ALIVE AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12311636 ↗
• MalfunctionApr 16, 2021Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING UNKNOWN INDICATION FOR ACDF C4-C6, CORPECTOMY C5. IT WAS REPORTED THAT SURGEON WAS UNABLE TO PROPERLY USE PROVISIONAL TIGHTENING RING TO PROVISIONALLY TIGHTEN CAGE IN EXPANDED POSITION. HE INDICATED THAT THE NUT/COLLAR WOULD NOT SPIN APPROPRIATELY. THE IMPLANT WOULD THEN NOT RELEASE PROPERLY FROM INSERTER ONCE IMPLANT WAS FINALLY IN PLACE. AFTER UNLOCKING INSERTER FROM IMPLANT SURGEON ATTEMPTED TO REMOVE IT BUT IMPLANT STUCK TO THE INSERTER AND PULLED OUT OF THE PATIENTS SURGICAL SITE. THE EVENT RESULTED IN EXTENDED OPERATIVE TIME. THE DELAY WAS APPROX. 30 MINS. THERE WERE NO PATIENT SYMPTOMS/ COMPLICATIONS AS A RESULT OF THE EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11676735 ↗
• InjuryApr 19, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PARTIAL CORPECTOMY AT T8/9 DUE TO TUMOR REMOVAL AND CORPECTOMY. POST-OP, IT WAS FOUND THAT THE IMPLANTED CAGE MIGRATE A BIT. ALSO LOOSE A ONE TO TWO MILLIMETERS OF HEIGHT. HENCE ON (B)(6) 2020, REVISION SURGERY WAS PERFORMED IN WHICH THE CAGE WAS REMOVED. PATIENT HAD WOUND INFECTION AT INCISION, INITIAL INTENTION WAS TO REPOSITION IMPLANT, MOVE FORWARD. PATIENT HAD ¿WEAK¿ BONE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 9975749 ↗
• InjuryOct 1, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CORPECTOMY AT C6. POST-OPERATIVELY, THE CAGE SUBSIDED INTO C7. THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH THE SURGEON REMOVED THE CAGE, AND EXTENDED THE FUSION, DOING A CORPECTOMY AT C7. THERE WERE NO OTHER PATIENT COMPLICATIONS AS A RESULT OF ALLEGED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9138781 ↗