uCentum™ comprehensive posterior system CS 3802-055-050Recalls & reported problems
Ulrich GmbH & Co. KG · Screw, polyaxial, Ø 5.5 mm, length 50 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04052536078783), received between Oct 22, 2019 and Oct 22, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
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
- Fracture1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 2019Fracture; Fracture
DURING THE FOLLOW-UP LUMBAR SPINE X-RAY ON (B)(6) 2019 IN THE OUTPATIENT CLINIC, A SCREW FRACTURE WAS DETECTED. THERE IS CURRENTLY NO NEED FOR REVISION SURGERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9218056 ↗
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.
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