CRESCENT™ Spinal System 7968212Recalls & reported problems
Medtronic Sofamor Danek, Inc. · ASSEMBLY 7968212 M 37X27 12MM 12 DEG CP · 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 00613994517791), received between Nov 10, 2017 and Nov 10, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Migration or Expulsion of Device1
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.
InjuryNov 10, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: L5/S1 SPONDYLOLISTHESIS, CENTRAL STENOSIS IT WAS REPORTED THAT POST-OP, THE WHOLE CONSTRUCT, INCLUDING PLATE, INTERBODY CAGE, AND SCREWS ALL MIGRATED TO THE ANTERIOR. PATIENT REPORTEDLY HAD BACK PAIN AND LEG PAIN. SURGEON WAS IDENTIFYING OPTIONS FOR ADDITIONAL TREATMENT. PATIENT WAS UNSTABLE AND REQUIRE ADDITIONAL SURGERY.
Patient problems: Pain
MAUDE report 7017677 ↗
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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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