Capstone Control PTC Spinal System 5001222Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169679764), received between Jul 24, 2019 and Apr 17, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• MalfunctionApr 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING POSTERIOR L UMBAR INTERBODY FUSION. FOR LOWER SEGMENT CESAREAN SECTION (LSCS). IT WAS REPORTED THAT ALTHOUGH THERE WERE NO PROBLEMS WITH THE CAPSTONE CONTROL PTC 6° 12×22 PLACED ON THE RIGHT SIDE OF L3/4 IMMEDIATELY AFTER INSTALLATION, A BONE TRANSPLANT WAS PLACED ON THE MIDL INE AND A CAGE OF THE SAME SIZE WAS PLACED ON THE LEFT SIDE. AFTER THAT, THE CAGE WAS DROPPED NEAR THE OUTER PSOAS. THE PHYSICIAN DETERMINED THAT REMOVAL FROM THE BACK WAS DIFFICULT, AND THAT THERE WAS NO ADVERSE EFFECT ON TISSUE SUCH AS BLOOD VESSELS, SO THE CAGE WAS LEFT AS IS. ON THE RIGHT SIDE OF L3/4, CAPSTONE PTC 12×22 WAS PLACED AND THE PROCEDURE PROCEEDED TO SCREW INSERTION. THERE WAS DELAY OF LESS THAN 60 MINS. 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 21855057 ↗
• InjuryJul 24, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-L5. THE PATIENT WAS IMPLANTED WITH THE REPORTED CAGE ALONG WITH THE NUVA MANUFACTURED SCREW. ON AN UNKNOWN DATE, POST-OP, THE IMPLANTED CAGE BACKED OUT. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY, IN WHICH, THE BACKED OUT CAGE WAS REPLACED WITH A CAGE OF BIGGER SIZE (14MM). PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND PATIENT'S ISSUE HAS BEEN REPORTED AS RESOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8821170 ↗