CapSure® Spine System 11-3000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10840642103953), received between Mar 9, 2018 and Mar 14, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (2 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, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 14, 2020Material Separation

  APPROXIMATELY 6 MONTHS POST-OPERATIVELY, A PATIENT REPORTEDLY EXPERIENCED PAIN. A SURGICAL PROCEDURE WAS PERFORMED AT WHICH TIME THE SURGEON IDENTIFIED A SINGLE SET SCREW SEPARATED FROM ONE PEDICLE SCREW IN THE CONSTRUCT. THE SET SCREW AND PEDICLE SCREW CONSTRUCT WERE REPLACED AND THE CONSTRUCT EXTENDED.

  Patient problems: Pain

  MAUDE report 9832611 ↗
• InjurySep 7, 2018Break; Loose or Intermittent Connection

  THE SURGEON REPORTED THAT MULTIPLE SET SCREWS WERE LOOSE IN A MULTI-LEVEL PEDICLE SCREW CONSTRUCT APPROXIMATELY ONE YEAR POST-OPERATIVELY. ADDITIONALLY, THE ROD ON ONE SIDE WAS BROKEN. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE AFFECTED SET SCREWS, SCREWS AND ROD IN THE CONSTRUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7857594 ↗
• InjuryMar 9, 2018Loose or Intermittent Connection

  THE SURGEON REPORTED THAT A SINGLE SET SCREW IN THE TWO LEVEL PEDICLE SCREW CONSTRUCT WAS LOOSE POST-OPERATIVELY. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE SET SCREW AND ANOTHER SCREW IN THE CONSTRUCT.

  Patient problems: Failure of Implant

  MAUDE report 7328766 ↗