uCentum comprehensive posterior systemRecalls & reported problems across all models
Ulrich GmbH & Co. KG · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 66
- Deaths reported
- 0
- Injuries reported
- 52
- Recalls
- 0
We found 15 models of uCentum comprehensive posterior system by Ulrich GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 66 adverse event reports in the FDA's MAUDE database, received between Sep 29, 2016 and Jan 3, 2025 — classified as 52 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Fracture” (22 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported uCentum comprehensive posterior system problems
Device problems
- Fracture22
- Break12
- Material Fragmentation10
- Detachment of Device or Device Component6
- Device Handling Problem5
- Material Separation4
- Migration4
- Unintended Movement4
Patient problems
- Failure of Implant58
- Pain9
- Discomfort5
- No Known Impact Or Consequence To Patient5
- Inadequate Osseointegration4
- Injury4
- Foreign Body In Patient2
- Device Embedded In Tissue or Plaque1
uCentum comprehensive posterior system models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- uCentum™ comprehensive posterior system CS 3802-065-050Orthosis, spinal pedicle fixation, for degenerative disc disease16 reports
- uCentum™ comprehensive posterior system CS 3801-01Orthosis, spinal pedicle fixation, for degenerative disc disease12 reports
- uCentum™ comprehensive posterior system CS 3810-01ORTHOSIS, SPINAL PEDICLE FIXATION7 reports
- uCentum™ comprehensive posterior system CS 3802-055-040Orthosis, spondylolisthesis spinal fixation6 reports
- uCentum™ comprehensive posterior system CS 3802-065-045Orthosis, spinal pedicle fixation, for degenerative disc disease5 reports
- uCentum™ comprehensive posterior system CS 3804-065-045ORTHOSIS, SPINAL PEDICLE FIXATION4 reports
- uCentum™ comprehensive posterior system CS 3802-075-045Orthosis, spinal pedicle fixation, for degenerative disc disease3 reports
- uCentum™ comprehensive posterior system CS 3810-03Orthosis, spinal pedicle fixation, for degenerative disc disease3 reports
- uCentum™ comprehensive posterior system CS 3802-065-055Orthosis, spondylolisthesis spinal fixation2 reports
- uCentum™ comprehensive posterior system CS 3810-00Orthosis, spondylolisthesis spinal fixation2 reports
- uCentum™ comprehensive posterior system CS 3885-085-045ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- uCentum™ comprehensive posterior system CS 3802-055-050ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- uCentum™ comprehensive posterior system CS 3802-075-035Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- uCentum™ comprehensive posterior system CS 3804-065-040ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- uCentum™ comprehensive posterior system CS 3805-075-050Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
Recent uCentum comprehensive posterior system adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJan 3, 2025Fracture; Fracture
ACCORDING TO USER INFORMATION, A PEDICLE SCREW BROKE AFTER APPROXIMATELY 18 TO 24 MONTHS OF IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 21072197 ↗InjuryJan 3, 2025Fracture; Fracture
ACCORDING TO USER INFORMATION. A PEDICLE SCREW BROKE AFTER APPROXIMATELY 18 TO 24 MONTHS OF IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 21072057 ↗InjuryJan 3, 2025Fracture; Fracture
ACCORDING TO USER INFORMATION, A PEDICLE SCREW BROKE AFTER APPROXIMATELY 18 TO 24 MONTHS OF IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 21069225 ↗InjuryJan 3, 2025Fracture; Fracture
ACCORDING TO USER INFORMATION. A PEDICLE SCREW BROKE AFTER APPROXIMATELY 18 TO 24 MONTHS OF IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 21068841 ↗InjuryDec 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORT: DURING THE IMPLANTATION OF A PEDICLE SCREW, AN UNNOTICED DISLOCATION OF THE INLAY OF THE SCREW OCCURRED WITHOUT ANY APPLICATION OF FORCE. A LONGITUDINAL ROD WAS ABLE TO BE PROPERLY BLOCKED WITH THE HEAD SCREW WITHOUT ANY PROBLEMS. THE DISLOCATED PART WAS NOT NOTICEABLE IN THE INTRAOPERATIVE IMAGE. THE DISLOCATED PART OF THE SCREW COULD ONLY BE DETECTED IN THE POSTOPERATIVE X-RAY AND THE PATIENT HAD TO BE REVISED. THE PATIENT INSISTED ON RETAINING THE SCREW.
Patient problems: Failure of Implant
MAUDE report 20864232 ↗InjuryDec 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORT: DURING THE IMPLANTATION OF A PEDICLE SCREW, AN UNNOTICED DISLOCATION OF THE INLAY OF THE SCREW OCCURRED WITHOUT ANY APPLICATION OF FORCE. A LONGITUDINAL ROD WAS ABLE TO BE PROPERLY BLOCKED WITH THE HEAD SCREW WITHOUT ANY PROBLEMS. THE DISLOCATED PART WAS NOT NOTICEABLE IN THE INTRAOPERATIVE IMAGE. THE DISLOCATED PART OF THE SCREW COULD ONLY BE DETECTED IN THE POSTOPERATIVE X-RAY AND THE PATIENT HAD TO BE REVISED. THE PATIENT INSISTED ON RETAINING THE SCREW AFTER THE REVISION SURGERY.
Patient problems: Failure of Implant
MAUDE report 20858238 ↗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 ↗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 ↗
Other Ulrich GmbH & Co. KG products
All Ulrich GmbH & Co. KG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 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