Capstone Control PTC Spinal System 5021322Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169677715), received between Nov 6, 2018 and Nov 6, 2018 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2018Break; Difficult to Remove; Break; Difficult to Remove

  PRE-OP DIAGNOSIS: THORACOLUMBAR VERTEBRA KYPHOSCOLIOSIS PROCEDURE USED: T9-S2AI PLIF (POSTERIOR LUMBAR INTERBODY FUSION) IT WAS REPORTED THAT INTRA-OP, SPACERS WERE USED AT L5/S BUT WERE NOT ABLE TO ROTATE PROPERLY AND HENCE WERE REMOVED BY POSITION ADJUSTMENT. THE THREADED PART OF SPACERS BROKE DURING PULLING. NO FRAGMENTS REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8040809 ↗
• MalfunctionNov 6, 2018Break; Difficult to Remove; Break; Difficult to Remove

  PRE-OP DIAGNOSIS: THORACOLUMBAR VERTEBRA KYPHOSCOLIOSIS PROCEDURE USED: T9-S2AI PLIF (POSTERIOR LUMBAR INTERBODY FUSION) IT WAS REPORTED THAT INTRA-OP, SPACERS WERE USED AT L5/S BUT WERE NOT ABLE TO ROTATE PROPERLY AND HENCE WERE REMOVED BY POSITION ADJUSTMENT. THE THREADED PART OF SPACERS BROKE DURING PULLING. NO FRAGMENTS REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8040808 ↗