uCentum™ comprehensive posterior system CS 3802-065-050Recalls & reported problems
Ulrich GmbH & Co. KG · Screw, polyaxial, Ø 6.5 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
- 16
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04052536078844), received between Oct 5, 2016 and Sep 17, 2024 — classified as 12 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (10 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.
Reports received per month
Most reported problems
Device problems
- Fracture10
- Break3
- Insufficient Device Problem Information2
- Device Handling Problem1
- Use of Incorrect Control/Treatment Settings1
Patient problems
- Failure of Implant16
- Pain4
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2024Fracture; Fracture
ACCORDING TO USER INFORMATION, THE DOCTOR CONDUCTED A REVISION SURGERY DUE TO INSTABILITY IN THE CONSTRUCT. DURING THE OPERATION IT WAS FOUND THAT ONE SCREW WAS BROKEN. THE BROKEN SCREW WAS PARTIALLY REMOVED. THE SCREW TIP COULD NOT BE REMOVED AND WAS LEFT IN THE PATIENT.
Patient problems: Failure of Implant
MAUDE report 20240486 ↗InjurySep 4, 2024Fracture; Fracture
ACCORDING TO USER INFORMATION. THE DOCTOR CONDUCTED A REVISION SURGERY DUE TO INSTABILITY IN THE CONSTRUCT. DURING THE OPERATION IT WAS FOUND THAT ONE SCREW WAS BROKEN. THE BROKEN SCREW WAS PARTIALLY REMOVED. THE SCREW TIP COULD NOT BE REMOVED AND WAS LEFT IN THE PATIENT.
Patient problems: Failure of Implant
MAUDE report 20140915 ↗InjuryJun 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
WHEN INSERTING THE ROD INTO THE TULIP HEAD THE DOCTOR COMPLAINED THE ROD WAS NOT INSERTED IN THE DESIRED POSITION. USE OF THE PERSUADER DID NOT HELP. THE SCREW WAS UNABLE TO BE INSERTED INTO THE TULIP HEAD. THERE WAS NO ALTERNATIVE BUT TO REPLACE THE PEDICLE SCREW INTRAOPERATIIVELY CAUSING AN EXTENSION OF TIME TO THE SURGERY, OF APPROXIMATELY 60 TO 90 MINUTES.
Patient problems: Failure of Implant
MAUDE report 19563751 ↗MalfunctionJun 18, 2024Use of Incorrect Control/Treatment Settings; Insufficient Device Problem Information; Use of Incorrect Control/Treatment Settings; Insufficient Device Problem Information
WHEN INSERTING THE ROD INTO THE TULIP HEAD THE DOCTOR COMPLAINED THE ROD WAS NOT INSERTED IN THE DESIRED POSITION. USE OF THE PERSAUADER DID NOT HELP. THE SET SCREW WAS UNABLE TO BE INSERTED INTO THE TULIP HEAD. THERE WAS NO ALTERNATIVE BUT TO REPLACE THE PEDICLE SCREW INTRAOPERATIVELY CAUSING AN EXTENSION OF TIME TO THE SURGERY OF APPROXIMATELY 60 TO 90 MINUTES.
Patient problems: Failure of Implant
MAUDE report 19562797 ↗InjuryDec 9, 2022Fracture; Fracture
InjuryDec 9, 2022Fracture; Fracture
MalfunctionApr 28, 2022Fracture; Fracture
UCENTUM PEDICLE SCREW: WHEN UNSCREWING THE PEDICLE SCREW, THE SCREW TIP BROKE OFF IMMEDIATELY AT THE CEMENT PERFORATIONS. THE RESIDUAL SCREW REMAINED IN THE PATIENT.
Patient problems: Failure of Implant
MAUDE report 14241912 ↗InjuryApr 28, 2022Fracture; Fracture
UCENTUM PEDICLE SCREW: WHEN UNSCREWING THE PEDICLE SCREW, THE SCREW TIP BROKE OFF IMMEDIATELY AT THE CEMENT PERFORATIONS. THE RESIDUAL SCREW REMAINED IN THE PATIENT.
Patient problems: Failure of Implant
MAUDE report 14241898 ↗InjuryNov 10, 2020Fracture; Fracture
SCREW BREAKAGE. SEE MANUFACTURER NARRATIVE FOR DETAILS. REPORT 2 OF 2.
Patient problems: Failure of Implant; Pain
MAUDE report 10819706 ↗InjuryNov 10, 2020Fracture; Fracture
SCREW BREAKAGE. SEE MANUFACTURER NARRATIVE FOR DETAILS. REPORT 1 OF 2.
Patient problems: Failure of Implant; Pain
MAUDE report 10819705 ↗InjurySep 21, 2020Fracture; Fracture
InjurySep 21, 2020Fracture; Fracture
SCREW BREAKAGE. SEE MANUFACTURER NARRATIVE FOR DETAILS. REPORT 1 OF 2..
Patient problems: Failure of Implant; Pain
MAUDE report 10563422 ↗InjuryDec 26, 2018Device Handling Problem; Device Handling Problem
SET SCREWS WOULD NOT ENGAGE THE PEDICLE SCREW.
Patient problems: Failure of Implant
MAUDE report 8197766 ↗InjurySep 7, 2017Break; Break
MalfunctionMar 15, 2017Break; Break
MalfunctionOct 5, 2016Break; 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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