uCentum™ comprehensive posterior system CS 3804-065-045Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04052536079551), received between May 15, 2018 and Dec 6, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (2 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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryJun 21, 2018Break; Break

  TWO PRE-FIXATION SCREWS IN S1 BROKE (ONE DIRECTILY UNDERNEATH THE SCREW HEAD AND THE OTHER AT THE MIDDLE OF THE THREAD). A REVISION WAS DONE TO REPLACE THE BROKEN SCREWS.

  Patient problems: Discomfort; Failure of Implant; Pain

  MAUDE report 7626966 ↗
• InjuryMay 15, 2018Break; Break

  PRE-FIXATION SCREW IN S1 BROKE DIRECTLY UNDERNEATH THE SCREW HEAD AND HAD TO BE REPLACED.

  Patient problems: Discomfort; Pain

  MAUDE report 7516478 ↗

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 · Terminated
  ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.