uCentum™ comprehensive posterior system CS 3801-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04052536078646), received between Mar 8, 2017 and Jun 28, 2019 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJun 28, 2019Device Handling Problem; Device Handling Problem

  SET SCREWS WOULD NOT ENGAGE THE PEDICLE SCREW. REPORT 3/4.

  Patient problems: Failure of Implant

  MAUDE report 8745575 ↗
• InjuryJun 28, 2019Device Handling Problem; Device Handling Problem

  SET SCREWS WOULD NOT ENGAGE THE PEDICLE SCREW. REPORT 2/4.

  Patient problems: Failure of Implant

  MAUDE report 8745573 ↗
• InjuryJun 28, 2019Device Handling Problem; Device Handling Problem

  SET SCREWS WOULD NOT ENGAGE THE PEDICLE SCREW. REPORT 4/4.

  Patient problems: Failure of Implant

  MAUDE report 8745569 ↗
• InjuryJun 28, 2019Migration; Migration

  SURGEON USED STANDARD SET SCREWS WITH PREFIXATION SCREWS INSTEAD OF THE PREFIXATION SET SCREWS THAT FIT WITH THEM. POST OP X-RAYS REVEALED ROD WAS MIGRATING. REVISION WAS DONE (B)(6) 2018 REPOSITIONING THE ROD AND REPLACING STANDARD SET SCREWS WITH CORRECT PREFIXATION SET SCREWS. REPORT 3/4.

  Patient problems: Failure of Implant; Injury

  MAUDE report 8745564 ↗
• InjuryJun 28, 2019Migration; Migration

  SURGEON USED STANDARD SET SCREWS WITH PREFIXATION SCREWS INSTEAD OF THE PREFIXATION SET SCREWS THAT FIT WITH THEM. POST OP X-RAYS REVEALED ROD WAS MIGRATING. REVISION WAS DONE (B)(6) 2018 REPOSITIONING THE ROD AND REPLACING STANDARD SET SCREWS WITH CORRECT PREFIXATION SET SCREWS. REPORT 4/4.

  Patient problems: Failure of Implant; Injury

  MAUDE report 8745548 ↗
• InjuryJun 28, 2019Migration; Migration

  SURGEON USED STANDARD SET SCREWS WITH PREFIXATION SCREWS INSTEAD OF THE PREFIXATION SET SCREWS THAT FIT WITH THEM. POST OP X-RAYS REVEALED ROD WAS MIGRATING. REVISION WAS DONE (B)(6) 2018 REPOSITIONING THE ROD AND REPLACING STANDARD SET SCREWS WITH CORRECT PREFIXATION SET SCREWS. REPORT 2/4.

  Patient problems: Failure of Implant; Injury

  MAUDE report 8745544 ↗
• InjuryOct 30, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  TWO LOCKING SCREWS DISASSOCIATED POSTOPERATIVELY FROM THE PEDICLE SCREWS AND HAD TO BE REPLACED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8018842 ↗
• InjuryAug 7, 2018Migration; Migration

  SURGEON USED STANDARD SET SCREWS WITH PREFIXATION SCREWS INSTEAD OF THE PREFIXATION SET SCREWS THAT FIT WITH THEM. POST OP X-RAYS REVEALED ROD WAS MIGRATING. REVISION WAS DONE (B)(6) 2018 REPOSITIONING THE ROD AND REPLACING STANDARD SET SCREWS WITH CORRECT PREFIXATION SET SCREWS.

  Patient problems: Failure of Implant; Injury

  MAUDE report 7757447 ↗
• InjuryMar 29, 2018Material Separation; Unintended Movement; Material Separation; Unintended Movement

  ONE LOCKING SCREW SEPARATED POSTOPERATIVELY FROM THE PEDICLE SCREW. NO REVISION HAS OCCURRED AS OF NOW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7381532 ↗
• InjuryMar 29, 2018Material Separation; Unintended Movement; Material Separation; Unintended Movement

  ONE LOCKING SCREW SEPARATED POSTOPERATIVELY FROM THE PEDICLE SCREW AND A REVISION WAS DONE TO REPLACE THE LOCKING SCREW.

  Patient problems: Failure of Implant

  MAUDE report 7381530 ↗
• InjuryMar 29, 2018Material Separation; Unintended Movement; Material Separation; Unintended Movement

  TWO LOCKING SCREWS SEPARATED POSTOPERATIVELY FROM THE PEDICLE SCREWS AND A REVISION WAS DONE TO REPLACE THE LOCKING SCREWS.

  Patient problems: Failure of Implant

  MAUDE report 7381524 ↗
• MalfunctionMar 8, 2017Detachment Of Device Component; Material Separation; Unintended Movement; Detachment Of Device Component; Material Separation; Unintended Movement

  THE LOCKING SET SCREW LOOKED TO BE SITTING OFF THE TOP LEFT SCREW IN A FOLLOW UP MRI. A REVISION SURGERY WAS CONDUCTED REVEALING THAT THE SET SCREW WAS IN FACT OUT OF THE HEAD OF THE SCREW. BOTH THE SET SCREW AND SCREW WERE EXPLANTED AND DISCARDED BY THE HOSPITAL.

  Patient problems: Failure of Implant

  MAUDE report 6388916 ↗

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.