uCentum™ comprehensive posterior system CS 3810-01Recalls & reported problems
Ulrich GmbH & Co. KG · Crosslink variable, XS, length 41 - 56 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
- 7
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04052536080854), received between Jun 28, 2019 and Feb 6, 2020 — classified as 5 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (5 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 Fragmentation5
- Fracture2
Patient problems
- Failure of Implant7
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryFeb 6, 2020Fracture; Fracture
A CROSSLINK BROKE IN SURGERY DURING FINAL TIGHTENING. IT WAS REMOVED AND REPLACED WITH NO EFFECT ON THE PATIENT.
Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient
MAUDE report 9678087 ↗MalfunctionFeb 6, 2020Fracture; Fracture
A CROSSLINK BROKE IN SURGERY DURING FINAL TIGHTENING. IT WAS REMOVED AND REPLACED WITH NO EFFECT ON THE PATIENT.
Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient
MAUDE report 9677923 ↗InjuryAug 30, 2019Material Fragmentation; Material Fragmentation
CROSSLINK SNAPPED DURING FINAL TIGHTENING. REPORT 2 OF 3.
Patient problems: Failure of Implant
MAUDE report 8950393 ↗InjuryAug 30, 2019Material Fragmentation; Material Fragmentation
CROSSLINK SNAPPED ON FINAL TIGHTENING. REPORT 1 OF 3.
Patient problems: Failure of Implant
MAUDE report 8950391 ↗InjuryAug 30, 2019Material Fragmentation; Material Fragmentation
CROSSLINK SNAPPED ON FINAL TIGHTENING. REPORT 2 OF 3.
Patient problems: Failure of Implant
MAUDE report 8950389 ↗InjuryAug 30, 2019Material Fragmentation; Material Fragmentation
CROSSLINK SNAPPED DURING FINAL TIGHTENING. REPORT 1 OF 3.
Patient problems: Failure of Implant
MAUDE report 8950387 ↗MalfunctionJun 28, 2019Material Fragmentation; Material Fragmentation
CROSSLINK BROKE DURING CASE DUE TO INCORRECT INSTRUMENT BEING USED.
Patient problems: Failure of Implant
MAUDE report 8745572 ↗
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 devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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.
How reports and recalls are matched · Editorial policy · Report an error on this page