NA 495.399Recalls & reported problems
Synthes GmbH · END RING 26MM X 33MM ANTEROLATERAL/0 DEG (TI) · Class 2 · Implant
Data updated Oct 16, 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 10705034785592), received between Oct 26, 2021 and Oct 26, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Material Integrity Problem” (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
Device problems
- Material Integrity Problem1
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.
InjuryOct 26, 2021Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT, THE PATIENT UNDERWENT REVISION SURGERY DUE TO FRACTURE OF THE RODS BILATERALLY AT APPROXIMATELY T10 LEVEL (ABOVE CORPECTOMY SITE) AND COLLAPSE OF THE TI SYNMESH CAGE, WITH EVIDENCE THE CAGE FRACTURED/BROKE AND FELL INTO ITSELF. LATER THE PATIENT UNDERWENT A T10/11 CORPECTOMY WITH CAGE PLACEMENT AND T8-L1 PEDICLE SCREW FIXATION (B)(6) 2018. THE PATIENT PRESENTED WITH PAIN AROUND (B)(6) 2021 AND SUBSEQUENT IMAGING SHOWED THE FOLLOWING HARDWARE FAILURE: 1. FRACTURE OF THE RODS BILATERALLY AT APPROXIMATELY T10 LEVEL (ABOVE CORPECTOMY SITE) 2. COLLAPSE OF THE TI SYNMESH CAGE, WITH EVIDENCE OF THE CAGE FRACTURED/BROKE AND FELL INTO ITSELF. ON (B)(6) 2021, THE SURGEON REVISED THE BROKEN RODS POSTERIORLY AND PLACED FOUR COCR RODS WITH PARALLEL CONNECTORS TO STABILIZE THE SPINE. THE SURGEON RESECTED SCAR TISSUE POSTERIORLY TO FREE UP THE DAMAGED CAGE AS MUCH AS POSSIBLE. AFTER THE INTRA-OPERATIVE ASSESSMENT, THE SURGEON DETERMINED IT WOULD BE BEST TO REVISE THE CAGE ANTERIORLY WITH THE HELP OF THE THORACIC AND VASCULAR SURGEONS. ON (B)(6) 2021, THE SURGEON WAS ABLE TO SAFELY EXTRACT THE BROKEN CAGE. SCAR TISSUE HAD FORMED ACROSS THE T10/11 LEVEL, ADHERING THE CAGE TO V
Patient problems: Pain
MAUDE report 12697468 ↗
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- X-CORE 7160012Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
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- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7160014Nuvasive, 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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