Capstone Control PTC Spinal System 5001122Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169679757), received between Jan 3, 2020 and Jan 5, 2026 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionJan 5, 2026No Apparent Adverse Event; Migration

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT HAVING L3-5 DIRECT DECOMPRESSION (BONY)/OSTEOTOMY, L3-5 INTERBODY FUSION AND L3-5 POSTERIOR SPINAL FIXATION AND FUSION THERAPY. IT WAS REPORTED THAT THERE WAS AN EVIDENCE OF FUSION WITH MILD SUBSIDENCE, L4.5 DISC LOOSENING AND SLIGHT LOSS OF DISC HEIGHT. 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 23956498 ↗
• MalfunctionJan 5, 2026No Apparent Adverse Event; Migration

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT HAVING L3-5 DIRECT DECOMPRESSION (BONY)/OSTEOTOMY, L3-5 INTERBODY FUSION AND L3-5 POSTERIOR SPINAL FIXATION AND FUSION THERAPY. IT WAS REPORTED THAT THERE WAS A EVIDENCE OF FUSION WITH MILD SUBSIDENCE, L4.5 DISC LOOSENING AND SLIGHT LOSS OF DISC HEIGHT. 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 23956417 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION AT L4-L5. ON AN UNKNOWN DATE, POST-OP, THE PATIENT COMPLAINED OF LOWER BACK PAIN. IT WAS CONFIRMED BY THE MRI IMAGE THAT BRIGHTNESS CHANGED AT UPPER L5 LEVEL; AND IT WAS SUSPECTED THAT THE PATIENT HAD INFECTION AS HE HAD A CRP VALUE OF 6.8. L4-L5 INTERVERTEBRAL INFECTION WAS SUSPECTED. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY, IN WHICH THE TWO CAGES AT L4-L5 LEVEL WERE REMOVED; AND ILIAC BONE GRAFTING WAS PERFORMED FROM THE ANTERIOR SIDE. ACCORDING TO THE HEALTHCARE PROFESSIONAL, IT CANNOT BE DETERMINED WHETHER THE INFECTION WAS CAUSED BY THE CAGES OR NOT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9548440 ↗