flamenco™ spinal fixation system CS 8010Recalls & reported problems
Ulrich GmbH & Co. KG · flamenco locking screw, silver, ø 9.0 mm, length 5 mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04052536021369), received between Jun 6, 2017 and Jun 28, 2019 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (5 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 16, 2026.
Most reported problems
Device problems
- Material Deformation5
Patient problems
- Failure of Implant5
- No Known Impact Or Consequence To Patient5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJun 28, 2019Material Deformation; Material Deformation
SCREWS AND LOCKING SCREWS WERE GETTING THREADS DAMAGED ON FINAL TIGHTENING. REPORT 2/7.
Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient
MAUDE report 8745562 ↗InjuryJun 28, 2019Material Deformation; Material Deformation
SCREWS AND LOCKING SCREWS WERE GETTING THREADS DAMAGED ON FINAL TIGHTENING. REPORT 3/7.
Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient
MAUDE report 8745561 ↗InjuryJun 28, 2019Material Deformation; Material Deformation
SCREWS AND LOCKING SCREWS WERE GETTING THREADS DAMAGED ON FINAL TIGHTENING. REPORT 5/7.
Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient
MAUDE report 8745546 ↗InjuryJun 28, 2019Material Deformation; Material Deformation
SCREWS AND LOCKING SCREWS WERE GETTING THREADS DAMAGED ON FINAL TIGHTENING. REPORT 4/7.
Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient
MAUDE report 8745541 ↗MalfunctionJun 6, 2017Material Deformation; Material Deformation
REPORT 1/7.
Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient
MAUDE report 6614235 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 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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