CAPSTONE® Spinal System 2991432Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994290908), received between Aug 21, 2020 and Feb 23, 2021 — classified as 3 malfunctions.

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

• MalfunctionFeb 23, 2021Break; Break

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING POSTERIOR SLIP RESET PROCEDURE IN A PATIENT DIAGNOSED WITH SPONDYLOLISTHESIS. IT WAS REPORTED THAT THE SPACER BROKE, THE SC REWDRIVER'S HOLDING PATTERN WAS DAMAGED AND IT WAS IMPOSSIBLE TO SCREW AND THE SET SCREWS SLIPPED. CAGE WAS PULLED OUT WITH TOOLS ON THE SPOT, NO SECONDARY SURGERY. PRODUCTS WILL BE RETURNED. NO PATIENT INJURY / COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11363835 ↗
• MalfunctionOct 9, 2020Material Fragmentation; Material Fragmentation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CAGE FOR A DISCECTOMY, LAMINECTOMY, AND POSTERIOR FIXATION (INTRA-OP). IT WAS REPORTED THAT THE CAGE BROKE AS IT WAS INSERTED INTO THE L5- S1 DISC SPACE. THE FRAGMENT OF THE IMPLANT WAS REMOVED FROM THE PATIENT. THE IMPLANT BROKE AND THERE WAS NO FRAGMENT OF THE IMPLANT REMAINING IN THE PATIENT'S BODY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT CAME IN CONTACT WITH THE REPORTED PRODUCT AS THE IMPLANT WAS REMOVED FROM THE L51 DISC SPACE. THE PRE-OP DIAGNOSIS WAS ANTEROLISTHESIS, L4-5, GR I AND RETROLISTHESIS, L5-S1, GR I WITH HIVD. THE LEVELS IMPLANTED WERE L5-S1. THE CAGE WAS EXPLANTED ON (B)(6) 2020. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10654202 ↗
• MalfunctionAug 21, 2020Break; Device Slipped; Break; Device Slipped

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH LUMBAR DEGENERATIVE DIAGNOSIS INVOLVED IN LUMBAR SPINAL FUSION THERAPY. IT WAS REPORTED DURING INTRA-OP, FUSE HOLDER SLIPPED AND BROKE. THERE WERE NO FRAGMENTS LEFT IN THE PATIENT BODY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10435649 ↗