uCentum™ comprehensive posterior system CS 3802-065-045Recalls & reported problems
Ulrich GmbH & Co. KG · Screw, polyaxial, Ø 6.5 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
- 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 04052536078837), received between Feb 24, 2017 and Feb 14, 2022 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture3
- Break2
Patient problems
- Failure of Implant4
- Discomfort1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryFeb 14, 2022Fracture; Fracture
APPROX. 2 YEARS AFTER IMPLANTATION THE POLYAXIAL SCREW FRACTURED BELOW THE TULIP IN L5, LEFT. DURING EXPLANTATION STILL A FRACTURE IN THE LOWER THIRD OF THE SCREW SHAFT. TIP OF SCREW COULD NOT BE REMOVED.
Patient problems: Failure of Implant
MAUDE report 13529546 ↗InjuryFeb 14, 2022Fracture; Fracture
APPROX. 2 YEARS AFTER IMPLANTATION THE POLYAXIAL SCREW FRACTURED BELOW THE TULIP IN L5, LEFT. DURING EXPLANTATION STILL A FRACTURE IN THE LOWER THIRD OF THE SCREW SHAFT. TIP OF SCREW COULD NOT BE REMOVED.
Patient problems: Failure of Implant
MAUDE report 13529528 ↗InjuryFeb 14, 2019Fracture; Fracture
THE PATIENT COMPLAINED OF PERSISTENT SYMPTOMS AND UNDERWENT A REVISION SURGERY. THE EXISTING INSTRUMENTATION WAS TO BE EXTENDED IN ORDER TO STABILIZE THE SPINE OVER A LONGER DISTANCE. WHEN REMOVING THE ALREADY IMPLANTED RODS, THE SURGEONS DETERMINED THAT THE SCREW WAS BROKEN AND REMOVED IT. A NEW LARGER DIAMETER SCREW WAS IMPLANTED.
Patient problems: Discomfort; Pain
MAUDE report 8340924 ↗InjuryJun 6, 2017Break; Break
MalfunctionFeb 24, 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
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- 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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