T2™ Spinal System 9391316Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994676511), received between Feb 23, 2020 and Jun 15, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2021Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF L1 COMPRESSED FRACTURE INVOLVED IN T11-L3 POSTERIOR FUSION (L1 SUBTOTAL REMOVAL). LEVELS IMPLANTED: T11-L3. IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT WITH A COMPRESSION FRACTURE OF L1 UNDERWENT SUBTOTAL RESECTION OF L1, REPLACED THE VE RTEBRAL BODY WITH THE CYLINDER, AND PERFORMED POSTERIOR FIXATION UP TO TH11-L3. AT THAT TIME, A BONE FRAGMENT (AUTOLOGOUS BONE) WAS FILLED AS A BONE TO BE TRANSPLANTED. POSTOPERATIVELY, LEFT LEG PAIN OCCURRED, AND MRI IMAGING CONFIRMED A FRACTURE OF THE END PLATE. IT IS UNKNOWN WHEN THE FRACTURE OCCURRED IN THE FINAL STAGES. A PIECE OF BONE IMPLANTED AS A TRANSPLANTED BONE PROTRUDED POSTERIORLY, CAUSING LEG PAIN, AND REOPERATION WAS PERFORMED ON (B)(6) 2021. IN THE REOPERATION, T2 WAS NOT EXPLANTED, THE BONE FRAGMENT PROTRUDING POSTERIORLY WAS REMOVED, AND THE OPERATION WAS COMPLETED. THE BONE FRAGMENT WAS AN AUTOLOGOUS BONE IMPLANTED AS A TRANSPLANT BONE. THE LEG PAIN WAS CAUSED BY A PIECE OF BONE PROTRUDING POSTERIORLY AT IMPLANTED LEVEL (L1). FRACTURE OF THE ENDPLATE OCCURRED. THE FRACTURE OF THE END PLATE DOES NOT SEEM TO BE THE

  Patient problems: Hernia; Pain

  MAUDE report 11997721 ↗
• InjuryFeb 23, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH KYPHOSIS AND T10 VERTEBRAL BODY FRACTURE; AND UNDERWENT POSTERIOR FIXATION AT T7-L3 AFTER T10 VERTEBRAL COLUMN RESECTION (VCR). INTRA-OP, AFTER VCR WAS PERFORMED AT T10 AND CYLINDER OF 13MM WAS PLACED AT T2, X-RAY (TAKEN AT THE TIME OF POSTERIOR FIXATION) REVEALED THAT THE CAGE DID NOT CONNECT WITH THE ENDPLATE OF T9. THE CRANIAL SIDE OF THE CAGE HAD DEVIATED TOWARDS THE ANTERIOR SIDE OF THE T9 VERTEBRAL BODY AND BLEEDING OCCURRED. SINCE THE IMAGE HAD NOT BEEN CONFIRMED WHEN PLACING THE CAGE, IT WAS CONSIDERED THAT THERE WAS A HIGH POSSIBILITY THAT THE INITIAL PLACING POSITION WAS ORIGINALLY AT THE ANTERIOR SIDE. BECAUSE OF A LARGE AMOUNT OF BLEEDING, THE SURGEON DECIDED TO GIVE UP DOING THE OPERATION SUCH AS RE-PLACEMENT OF THE CAGE, AND WOUND CLOSURE WAS PERFORMED AFTER FINISHING THE POSTERIOR FIXATION. THE END CAP WAS NOT USED. IT WAS SAID THAT THE CAGE SEEMED TO BE NOT CONTRACTED. THE PATIENT'S CONDITION WAS NOT CONFIRMED. THERE WAS DELAY OF MORE THAN 60 MINUTES IN OVERALL PROCEDURE. THE ASSISTANT SURGEON CONSIDERED THAT IT WAS NOT AN INJURY TO THE BLOOD VESSELS ETC.

  Patient problems: Blood Loss

  MAUDE report 9742945 ↗