CAPSTONE PTC™ Spinal System 3992208Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169187559), received between Oct 25, 2018 and Dec 16, 2021 — classified as 1 injury, 3 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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 16, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED PRODUCT. THE PROCEDURE WAS MENTIONED AS L5/S PLIF. IT WAS REPORTED THAT, CAGE WAS PLACED ON THE LEFT L5 / S, THE CAGE WAS TOO DEEP, SO THEY MADE AN ATTEMPT TO RETURN IT, BUT IT WAS TOO TIGHT TO RETURN. THEY TRIED IT AGAIN WITH A SLAP HAMMER CONCOMITANTLY, JUDGED THAT THE CAGE WAS IN A GOOD POSITION, AND WHEN THEY REMOVED THE IMPLANT HOLDER, A PART OF THE BROKEN IMPLANT STUCK. THERE WAS NO DELAY IN PROCEDURE REPORTED AS A RESULT OF PRODUCT MALFUNCTION. THE BROKEN PIECE OF CAGE WAS LEFT INSIDE THE PATIENT. THERE WAS NO ABNORMALITY FOUND WITH IMPLANT HOLDER INVOLVED IN THIS EVENT. THERE WAS NO REVISION SURGERY PLANNED TO RETRIEVE THE BROKEN CAGE FROM PATIENT BODY. THERE WAS NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT AND NO SYMPTOMS TO PATIENT OR PHYSICIAN WERE REPORTED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13016163 ↗
• MalfunctionDec 19, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION (PLIF) DUE TO LUMBAR SPINAL CANAL STENOSIS. INTRA-OP, THE INTERVERTEBRAL DISC SPACE WAS NARROW AND THE CAGE BREAK WHILE INSERTING. THERE WAS A DELAY OF LESS THAN 60 MIN IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO INFORMATION REGARDING THE PATIENT IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8178024 ↗
• InjuryNov 26, 2018Migration; Migration

  PRE-OPERATIVE DIAGNOSIS: SPONDYLOLISTHESIS PROCEDURE: POSTERIOR LUMBAR INTERBODY FUSION LEVEL IMPLANTED: L4/5 IT WAS REPORTED THAT THE PATIENT UNDERWENT PROCEDURE WHERE IN TWO SCREWS WERE INSERTED AT L4 AND TWO SCREWS WERE INSERTED AT L5 THROUGH PLIF PROCEDURE. POST-OP, CAGE BACKED OUT. REVISION SURGERY WAS PERFORMED AND CAGE WAS REMOVED AND DECOMPRESSION WAS PERFORMED. NO FRAGMENT REMAINS IN THE PATIENT. DUE TO CAGE BACKING OUT THE CAGE COMPRESSED THE NERVE AND NEUROLOGICAL SYMPTOMS WAS REPORTED AS RESULT OF THIS EVENT.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 8102555 ↗
• MalfunctionOct 25, 2018Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR CANAL STENOSIS AND UNDERWENT MINIMALLY INVASIVE SURGERY (MIS) - TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L2,3,4,5. POST-OP, AT L2/3, THE SPACER BACKED OUT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8007163 ↗