uCentum™ comprehensive posterior system CS 3802-075-045Recalls & reported problems
Ulrich GmbH & Co. KG · Screw, polyaxial, Ø 7.5 mm, length 45 mm perforated · 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
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04052536078899), received between Oct 20, 2017 and Jun 28, 2019 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Difficult to Remove1
Patient problems
- Failure of Implant2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 28, 2019Difficult to Remove; Difficult to Remove
THE SURGEON WAS NOT ABLE TO SUCCESSFULLY IMPLANT THE SCREW; TWO SCREWDRIVERS BROKE WHILE TRYING BUT REMAINED INTACT. HE DECIDED TO REMOVE THE SCREW AND BROKE ANOTHER SCREWDRIVER TRYING TO DO SO AND SEVERAL PIECES OF METAL BROKE OFF FROM THE SCREWDRIVER BUT WERE RECOVERED AND RETURNED ALONG WITH THE DRIVERS. THE SURGEON WAS ABLE TO REMOVE THE SCREW USING A ROD AND LOCKING SCREW. REPORT 4/5.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8746399 ↗InjuryJun 28, 2019Break; Break
InjuryOct 20, 2017Break; Break
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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