CAPSTONE PTC™ Spinal System 3992206Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169187573), received between Feb 7, 2017 and Oct 20, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2024Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A T9-IL SPINAL FUSION PROCEDURE IN A PATIENT DIAGNOSED WITH DEGENERATIVE SCOLIOSIS. IT WAS REPORTED THAT WHILE L5-S1 WAS QUITE NARROW, CAGE WAS OVER-INSERTED. AS SUCH, WHEN THE POSITION OF THE CAGE WAS SHIFTED TO THE DORSAL SIDE, IT WAS RETURNED WITH A SLIDE HAMMER, BUT IT DID NOT RETURN PROPERLY; THE DORSAL PORTION OF THE CAGE WAS DAMAGED. THE BACK PART OF THE CAGE WHICH WAS MISSING WAS ATTACHED TO THE INSERTER. NO FRAGMENTS ARE REMAINING IN THE PATIENT. THE CAGE BEING OVER-INSERTED AND GETTING DAMAGED WHEN IT WAS PULLED OUT WAS DUE TO ERROR. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20489857 ↗
• MalfunctionJun 9, 2020Break; Break

  PRE-OPERATIVE DIAGNOSIS: KYPHOSIS PROCEDURE PERFORMED: POSTERIOR LUMBAR INTERBODY FUSION (PLIF) WAS PERFORMED AT L5/S. INTRA-OP, CAGE WAS PLACED ON THE LEFT SIDE, AND WHEN AN ATTEMPT WAS MADE TO INSERT THE SECOND CAGE ON THE RIGHT SIDE THE SECOND CAGE BROKE. THE SECOND CAGE WAS REPLACED WITH ANOTHER CAGE, AND WHEN AN ATTEMPT WAS MADE TO INSERT THAT CAGE, THAT CAGE WAS ALSO BROKE. BREAKAGE OCCURRED AT THE POSITION WHERE THE TIP OF THE CAGE WAS SLIGHTLY ENTERED TO THE INTERVERTEBRAL DISC SPACE (THE ANTERIOR MARKER WAS ABOUT AT THE POSTERIOR WALL OF THE VERTEBRAL BODY). THERE WERE NO FRAGMENTS REMAINED IN THE PATIENT. THE INTERVERTEBRAL DISC SPACE WAS NARROW AND MOBILITY WAS POOR. SHAVER AND DISTRACTOR WERE USED BEFORE INSERTION. THERE WAS A LESS THAN 60 MINUTES DELAY IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10131975 ↗
• MalfunctionJun 9, 2020Break; Break

  PRE-OPERATIVE DIAGNOSIS: KYPHOSIS PROCEDURE PERFORMED: POSTERIOR LUMBAR INTERBODY FUSION (PLIF) WAS PERFORMED AT L5/S. INTRA-OP, CAGE WAS PLACED ON THE LEFT SIDE, AND WHEN AN ATTEMPT WAS MADE TO INSERT THE SECOND CAGE ON THE RIGHT SIDE THE SECOND CAGE BROKE. THE SECOND CAGE WAS REPLACED WITH ANOTHER CAGE, AND WHEN AN ATTEMPT WAS MADE TO INSERT THAT CAGE, THAT CAGE WAS ALSO BROKE. BREAKAGE OCCURRED AT THE POSITION WHERE THE TIP OF THE CAGE WAS SLIGHTLY ENTERED TO THE INTERVERTEBRAL DISC SPACE (THE ANTERIOR MARKER WAS ABOUT AT THE POSTERIOR WALL OF THE VERTEBRAL BODY). THERE WERE NO FRAGMENTS REMAINED IN THE PATIENT. THE INTERVERTEBRAL DISC SPACE WAS NARROW AND MOBILITY WAS POOR. SHAVER AND DISTRACTOR WERE USED BEFORE INSERTION. THERE WAS A LESS THAN 60 MINUTES DELAY IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10131968 ↗
• MalfunctionSep 20, 2018Crack; Crack

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR CANAL STENOSIS AND UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION. DURING THE SURGERY, THE CAGE CRACKED. AS THE INTER-VERTEBRAL DISC SPACE WAS NARROW, THE CAGE WAS INSERTED DURING DISTRACTION THROUGH THE EXTENDER. ADDITIONAL INSERTION WAS PERFORMED USING BONE IMPACTOR AND PLASTIC HAMMER. WHEN THE POSTERIOR SIDE OF THE CAGE WAS OBSERVED, A CRACK WAS FOUND. THE CAGE REMAINS IMPLANTED IN THE PATIENT. NO HEALTH DAMAGE TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7896482 ↗
• MalfunctionMay 30, 2018Break; Positioning Problem; Break; Positioning Problem

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE : LCS TYPE OF PROCEDURE OR TECHNIQUE USED: TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) LEVELS: L5/S1 IT WAS REPORTED THAT INTRA-OP, THE INTERVERTEBRAL DISC SPACE WAS MANAGED TO BE WIDENED FOR INSERTING THE CAGE. THE CAGE WAS INSERTED IN A WRONG DIRECTION. IT WAS HARD TO INSERT THE CAGE AND THE CAGE WAS BROKEN IN THE PROCESS OF BEING HIT. AFTER THAT, THE DIRECTION WAS CONFIRMED BY THE PERSPECTIVE IMAGE. IT WAS SAID THAT THERE WAS NO PROBLEM BECAUSE THE CAGE WAS INSERTED WITHOUT PROBLEMS AFTER THE IMAGE CONFIRMATION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7554987 ↗
• InjuryFeb 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, ON (B)(6) 2016, PATIENT PRESENTED WITH PRE-OPERATIVE DIAGNOSIS: TH12 BURST FRACTURE AND LUMBAR SPINAL CANAL STENOSIS AND UNDERWENT PROCEDURE: TH10/L3: POSTERIOR SPINAL FUSION, L2/3: POSTERIOR LUMBAR INTERBODY FUSION. ON (B)(6) 2017, POST-OP, INFECTION AT PLIF CAGE WAS OBSERVED. PATIENT DID NOT ACHIEVE SOLID FUSION DUE TO INFECTION. ON (B)(6) 2017, ANTERIOR FUSION(REMOVAL OF CAGE, BONE AUTOGRAFTING) WAS CONDUCTED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 6306314 ↗