CAPSTONE PTC™ Spinal System 3992611Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169187412), received between Mar 3, 2023 and Feb 7, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Align” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2025Failure to Align; Failure to Align

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING MINIMALLY INVASIVE TRAN SFORAMINAL LUMBAR INTERBODY FUSION (MIS TLIF). IT WAS REPORTED THAT THE INNER THREAD OF INSERTER WAS IDLE AND THE INSERTER CANNOT MOVE FORWARD AND ATTACH THE CAGE. A NEW SAME SIZE CAGE WAS OPENED AND ATTACHED SUCCESSFULLY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332011 ↗
• InjuryMar 3, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A CAPSTONE SPACER USED IN POSTERIOR SPINAL FUSION PROCEDURE. IT WAS REPORTED THAT THE CAGE AT L5/S BACKED OUT AND COMPRESSED THE SPINAL CORD. THE SCREW WAS ALSO LOOSE. CAUSE OF THIS EVENT UNKNOWN. REPEAT SURGERY SCHEDULED FOR (B)(6) 2023. THE PATIENT HAS BEEN OPERATED ON SEVERAL TIMES BEFORE AND NON-MEDTRONIC PRODUCT WAS THEN USED. DUE THIS EVENT, SPINAL CORD COMPRESSION OCCURRED TO PATIENT. PATIENT HAS NOT RECOVERED YET. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED ADDITIONAL INFORMATION RECEIVED THAT REVISION OPERATION WILL BE PERFORMED ON (B)(6) 2023. WHEN PRODUCT IS REMOVED/ EXPLANTED, IT WOULD BE RETURNED TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED THAT REVISION OPERATION WAS PERFORMED FEB/16. IN THIS SURGERY, PRE-OP DIAGNOSIS WAS LUMBAR SPINAL STENOSIS. PATIENT HAS BEEN EXPERIENCING PAIN FROM THE LEFT BUTTOCK TO THE LATERAL SURFACE OF THE LEFT LOWER LEG PRIOR TO REVISION SURGERY. PAST MEDICAL HISTORY: AF, HEMORRHOIDS, GASTRIC POLYP, SUBARACHNOID HEMORRHAGE, GASTRIC ULCER, CHOLECYSTITIS. PATIENT SURGICAL HISTORY: FIRST OPERATION ON (

  Patient problems: Pain; Spinal Cord Injury

  MAUDE report 16475929 ↗