T2™ Spinal System 9391633Recalls & reported problems
Medtronic Sofamor Danek, Inc. · CENTERPIECE 9391633 16 X 33MM 16E · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00613994676412), received between Jul 26, 2018 and Jul 26, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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
- Migration1
- Positioning Problem1
Patient problems
- Disability1
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 26, 2018Positioning Problem; Migration; Migration
PRE-OPERATIVE DIAGNOSIS: BURST FRACTURE TYPE OF PROCEDURE: ANTERIOR FIXATION POSTERIOR FIXATION LEVELS IMPLANTED: L2, L1-L3 IT WAS REPORTED THAT ON UNKNOWN DATE, POST-OP, POSTERIOR FIXATION OF L1-3 AND ANTERIOR FIXATION OF L2 WERE PERFORMED FOR BURST FRACTURE OF L2. DURING ANTERIOR FIXATION, T2 AND ILIAC BONE WERE PLACED. AFTER THE OPERATION, CAGE AT T2 BACKED OUT AND REVISION SURGERY WAS PERFORMED AT POSTERIOR PART ON (B)(6) 2018. IN THE OPINION OF THE PHYSICIAN, THERE WAS NO FALL DOWN ETC. BUT IT WAS CONSIDERED THAT T2 BACKED OUT BECAUSE OF T2 INSTALLATION POSITION AT FIRST AND SEVERE OSTEOPOROSIS. ACCORDING TO THE HEALTHCARE PROFESSIONAL'S OPINION, PATIENT SYMPTOMS OR COMPLICATIONS RESULT IN DISABILITY.
Patient problems: Disability; No Code Available
MAUDE report 7724695 ↗
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- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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