CAPSTONE PTC™ Spinal System 3992211Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169187528), received between Aug 17, 2017 and Jun 30, 2026 — classified as 3 injuries, 1 malfunction.

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

• MalfunctionJun 30, 2026Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM CLINICAL STUDY, HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CLINICAL ID: (B)(6), AND STUDY ID: TLIF IDE PIVOTAL - (B)(4). IT WAS REPORTED THAT DURING MMI IMAGING ANALYSIS, HARDWARE LOOSENING WAS OBSERVED. PATIENT WAS TREATED FOR 2 LEVELS. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO REVISION SURGERY PLANNED OR SCHEDULED FOR THE REMOVAL OF IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25662312 ↗
• InjuryOct 7, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY AT L4-L5 DUE TO STENOSIS. ON AN UNKNOWN DATE, POST-OP, THE CAGE BACKED OUT INSIDE THE PATIENT. LOWER LIMB PAIN OCCURRED AS A RESULT OF THIS EVENT. HENCE, A REVISION SURGERY WAS PERFORMED, IN WHICH CAGE REMOVAL AND SCREW REPLACEMENT ON THE LEFT OF L4-L5 WAS PERFORMED. REPORTEDLY, THE DOCTOR WAS TRYING TO USE A CAGE LARGER THAN 11MM DURING THE INITIAL SURGERY BUT THERE WERE NO CAGES WITH THAT SIZE, SO THE CAGE OF 11MM WAS USED INSTEAD.

  Patient problems: Pain

  MAUDE report 9160503 ↗
• InjuryOct 6, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY AT L5-S1 DUE TO RADICULOPATHY AT L5. A CAGE WAS IMPLANTED AT L5-S1 DURING THIS SURGERY. ON AN UNKNOWN DATE, POST-OP, THE PATIENT FELT SEVERE PAIN WHEN HE BENT DOWN TO PUT ON SOCKS OR STRETCHED TO MAKE IT EASIER TO MOVE. THEN, THE PATIENT GOT MEDICAL ATTENTION, AND IT WAS FOUND THAT THE CAGE HAD BACKED OUT. REPORTEDLY, RADICULOPATHY REOCCURRED AND THE PATIENT EXPERIENCED PAIN IN HIS LOWER LIMBS. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY, IN WHICH THE BACKED-OUT CAGE WAS COMPLETELY REMOVED, AND AUTOGENOUS BONE GRAFT WAS PERFORMED ADDITIONALLY.

  Patient problems: Neuropathy; Pain

  MAUDE report 9160277 ↗
• InjuryAug 17, 2017Malposition of Device; Malposition of Device

  PRE-OP DIAGNOSIS: ADJACENT SEGMENTAL DISORDER PROCEDURE: POSTERIOR LUMBAR INTERBODY FUSION LEVELS: L3/4/5 IT WAS REPORTED THAT DURING SURGERY, ON CONFIRMING VIA THE FLUOROSCOPIC IMAGE IT WAS FOUND THAT THE CAGE HAD BEEN INSERTED INTO THE POSTERIOR WALL OF L4 VERTEBRAL BODY INSTEAD OF THE L4/5 INTERVERTEBRAL DISC SPACE. THE CAGE WAS LEFT IN THE VERTEBRAL BODY. THERE WAS PROCEDURAL DELAY OF MORE THAN 60 MINUTES. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.

  Patient problems: Bone Fracture(s); Discomfort

  MAUDE report 6799715 ↗