flamenco™ spinal fixation system CS 8002-040Recalls & reported problems
Ulrich GmbH & Co. KG · flamenco rod, Ø 5.5 mm, length 40 mm, pre-bent · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04052536114245), received between Jan 15, 2020 and Jan 15, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (2 reports).
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 18, 2026.
Most reported problems
Device problems
- Fracture2
Patient problems
- Failure of Implant2
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 15, 2020Fracture; Fracture
APPROXIMATELY 16 MONTHS POST-OP, X-RAYS REVEALED NON-UNION. A REVISION SURGERY WAS DONE TO REMOVE ALL HARDWARE AND FOUND ONE SCREW AND ONE ROD WERE BROKEN. REPORT 2 OF 2.
Patient problems: Failure of Implant; Foreign Body In Patient
MAUDE report 9591585 ↗InjuryJan 15, 2020Fracture; Fracture
APPROXIMATELY 16 MONTHS POST-OP, X-RAYS REVEALED NON-UNION. A REVISION SURGERY WAS DONE TO REMOVE ALL HARDWARE AND FOUND ONE SCREW AND ONE ROD WERE BROKEN. REPORT 1 OF 2.
Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant
MAUDE report 9591582 ↗
Other Orthosis, spondylolisthesis spinal fixation devices
- CD HORIZON® Spinal System 7540020Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation257 reports
- MANTIS Redux 48289999Stryker Corporation · Orthosis, spondylolisthesis spinal fixation76 reports
- EXPEDIUM TOP NOTCH 179771555Depuy Spine, LLC · Orthosis, spondylolisthesis spinal fixation41 reports
- EXPEDIUM 179712650Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation31 reports
- EXPEDIUM VERSE 199721530Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
- CD HORIZON® Spinal System 7576545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation26 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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