Capstone Control PTC Spinal System 5011122Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169677517), received between May 7, 2020 and Jun 30, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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.

• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WITH CLINICALID: (B)(6) AND STUDY NAME AILLIANCE (B)(6). IT WAS REPORTED THAT THE PATIENT HAD LOWER INSTRUMENTED BODY FRACTURE (CORONAL SPLIT FRACTURE) L5 AND CONFIRMED WITH CT ON (B)(6) 2024 AND MRI ON (B)(6) 2024. DIAGNOSTIC TEST: X-RAY. DIAGNOSTIC TEST DATE: (B)(6) 2024. THE AE RESULT IN THE PROLONGATION OF AN EXISTING HOSPITALIZATION. START DATE OF THE HOSPITALIZATION: (B)(6) 2024. END DATE OF THE HOS PITALIZATION: (B)(6) 2024. INVESTIGATOR ASSESSMENT: THE ADVERSE EVENT WAS CONSIDERED PROBABLY RELATED TO THE STUDY PROCEDURE AND NOT RELATED TO THE MEDTRONIC CST DEVICE. SPONSOR ASSESSMENT: THE ADVERSE EVENT WAS CONSIDERED AS CAUSALLY RELATED TO THE STUDY PROCEDURE AND TO THE MEDTRONIC CST DEVICE. OUTCOME OF THIS AE: RECOVERED/RESOLVED AS OF (B)(6) 2024.

  Patient problems: Bone Fracture(s)

  MAUDE report 25662667 ↗
• MalfunctionMay 7, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LUMBAR CANAL STENOSIS; AND UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION OF 3 INTRAVERTEBRAL DISCS (L3-S1). INTRA-OP, AFTER INSERTING THE CAGE AT L4-L5, THERE WAS A SENSE OF INCONGRUITY WHEN ROTATING THE CAGE. WHEN THE CAGE WAS REMOVED, IT WAS FOUND THAT THE CAGE HAD BEEN TWISTED AND DEFORMED. ALSO, THE INSERTER'S TIP WAS FOUND TO BE WIDENED, THE SURGEON PLACED IT BACK WITH PLIERS AND THE INSERTER WAS CONTINUED TO BE USED. THE DEFORMED CAGE WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10032778 ↗