T2™ Spinal System 9391326Recalls & reported problems
Medtronic Sofamor Danek, Inc. · CENTERPIECE 9391326 13 X 26MM 13D · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994676481), received between Jul 12, 2019 and Jul 12, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 12, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL FUSION SURGERY AT T11/12 AND L2/3 DUE TO VERTEBRAL BODY COLLAPSE AND PSEUDOARTHROSIS OCCURRED TO L1. POST-OP, THE PATIENT FELL FROM THE BED AT THE 3RD DAY AFTER THE OPERATION AND ALSO TUMBLED SEVERAL TIMES. THE PATIENT DID NOT LISTEN TO THE HEALTHCARE PROFESSIONAL. THE SINKING AND MOVEMENT OF T2, AND THE LOAD TO THE SCREW OCCURRED DUE TO TUMBLING. PATIENT SUFFERED PAIN IN LUMBAR AND BACK AND PROLONGED HOSPITALIZATION AS A RESULT OF THIS EVENT. THE IMPLANTED CAGE WAS DEVIATED FROM ITS POSITION. PATIENT UNDERWENT REVISION SURGERY AS A RESULT OF THIS EVENT. IN WHICH, DOCTOR ADJUSTED THE POSITION OF THE CAGE, AND THE OPERATION WAS COMPLETED.
Patient problems: Pain
MAUDE report 8784038 ↗
Other SPINAL VERTEBRAL BODY REPLACEMENT DEVICE devices
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- X-CORE 7220016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-5 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7180018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 33-54 mm, 7-10 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-8 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7220018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.