uCentum™ comprehensive posterior system CS 3810-03Recalls & reported problems
Ulrich GmbH & Co. KG · crosslink variable, M, length 66 - 80 mm · Class 2 · Implant
All models of uCentum comprehensive posterior system (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04052536080878), received between Jun 28, 2019 and Jun 28, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (3 reports).
1 other recall cover devices cleared under the same FDA submission (K123717); they may or may not involve this specific model.
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
- Material Fragmentation3
Patient problems
- Failure of Implant3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 28, 2019Material Fragmentation; Material Fragmentation
A PIECE OF THE CROSS CONNECTOR BROKE WHEN THE SURGEON WAS TRYING TO PLACE IT OVER THE ROD IN SITU.
Patient problems: Failure of Implant
MAUDE report 8745580 ↗MalfunctionJun 28, 2019Material Fragmentation; Material Fragmentation
METAL SHAVINGS FROM SCREWS SHEERED OFF WHILE SURGEON WAS REMOVING THEM DURING INITIAL SURGERY TO REPOSITION THE PLATE. REPORT 2/2.
Patient problems: Failure of Implant
MAUDE report 8745578 ↗MalfunctionJun 28, 2019Material Fragmentation; Material Fragmentation
METAL SHAVINGS FROM SCREWS SHEERED OFF WHILE SURGEON WAS REMOVING THEM DURING INITIAL SURGERY TO REPOSITION THE PLATE. REPORT 1/2.
Patient problems: Failure of Implant
MAUDE report 8745574 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K123717. One submission often covers many models, so check the product and lot details in each record.
- Z-1126-2019 · Mar 8, 2019 · TerminatedULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.
Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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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