CAPSTONE PTC™ Spinal System 3992608Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169187443), received between Nov 28, 2017 and Jul 20, 2022 — classified as 2 injuries, 1 malfunction.

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.

• MalfunctionJul 20, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT WHEN THE DOCTOR STARTED TO IMPLANT THE CAGE DEEPER WITH THE HAMMER, THE CONNECTION PART OF THE CAGE WHERE LINK TO THE CAGE-HOLDER BROKE. IT WAS SUGGESTED TP REPLACE A NEW IMPLANT IF IT'S POSSIBLE. BUT DOCTOR REFUSED DUE TO THE PATIENT'S AGE AND CONDITIONS. HIS CONCERN WAS IF REMOVE THE CAGE WILL BREAK THE PATIENT'S ENDPLATE OR EVEN VERTEBRAL BODY. FINALLY, THE DOCTOR DECIDED JUST TO REMOVE THE BROKEN PARTS OF THE CAGE AND LEAVE IT IMPLANTED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THERE WERE NO FRAGMENTS OF THE IMPLANTS OR INSTRUMENTS REMAINED IN THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15066004 ↗
• InjuryMay 1, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-L5. AROUND TWO MONTHS POST-OP, WHEN THE PATIENT UNDERWENT X-RAY EXAMINATION, IT WAS FOUND THAT THE CAGE HAD BACKED-OUT FROM ITS POSITION. THE PATIENT ALSO COMPLAINED OF LOWER EXTREMITY PAIN. HENCE, ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY, IN WHICH THE BACKED-OUT CAGE WAS REMOVED AND WAS REPLACED WITH A CAGE OF DIFFERENT SIZE. PATIENT'S CONDITION WAS REPORTED TO HAVE IMPROVED NOW.

  Patient problems: Pain

  MAUDE report 8568356 ↗
• InjuryNov 28, 2017Break; Break

  IT WAS REPORTED THAT DURING SURGERY, A CAGE BROKE APART ON INSERTION DUE TO TIGHT DISC SPACE. DURAL TEAR WAS REPORTED AS A RESULT OF THE EVENT. NO FRAGMENTS REMAINED IN THE PATIENT'S DISC SPACE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Spinal Column Injury

  MAUDE report 7062573 ↗