Reprocessing Instructions for the Capstone Inserter 2990003Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00613994846266), received between Aug 9, 2017 and Mar 31, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Mechanical Problem

  INFORMATION RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSERTER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER DOESN'T THREAD INTO THE CAGE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24739418 ↗
• MalfunctionMar 11, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING MAXIMUM ACCESS SURGERY TRANSFORAMINAL LUMBAR INTERBODY FUSION (MAS TLIF) SPINAL THERAPY FOR DEGENERATIVE DISC DISEASE (DDD). IT WAS REPORTED THAT FOR THE RIGHT TUBE, THE DISTAL END IS BENT OR FLARING OUT AND FOR THE CAPSTONE INSERTER, WHEN TRYING TO ATTACH TO THE IMPLANT, THE THREADS ARE NOT CAPTURING THE IMPLANT SO CANNOT ATTACH. 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 24566956 ↗
• MalfunctionJan 9, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF AT L5/S. IT WAS REPORTED THAT ABOUT HALF THE TOTAL LENGTH OF THE THREADED PART AT THE TIP OF THE INNER SHAFT (ABOUT 3.5 MM) BROKE WHILE IT WAS STILL ATTACHED TO THE CAGE. THE BROKEN PART IS CONTAINED WITHIN THE CAGE AND DOES NOT PROTRUDE BEYOND IT. IT WAS DIFFICULT TO REMOVE THE CAGE AS A WHOLE, SO THE SURGEON DECIDED TO LEAVE IT IN AND CLOSE THE INCISION. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THERE WERE NO FRACTURES OR BENTS IN THE CAGE. THERE WAS NO MALFUNCTION WITH THE SECOND INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21109765 ↗
• MalfunctionNov 10, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAGNOSIS FOR LUMBAR SPINAL STENOSIS. PROCEDURE OR THERAPY PERFORMED WAS L5/S MIS -TLIF. IT WAS REPORTED THAT THE CAGE BACKED OUT AFTER SURGERY. GRIPPING BY SHAFT WAS DONE DURING CAGE REMOVAL. THE GRIPPING PORTION AT THE TIP OF THE SHAFT WAS BROKEN DUE TO THE TWISTING MOTION DURING REMOVAL. IT WAS BURIED IN THE CAGE. SINCE THE REAR PORTION OF THE CAGE HAD ALREADY EMERGED, REMOVAL WAS PERFORMED WITH NEEDLE-NOSE PLIERS. DUE TO THE NARROW OPERATIVE FIELD, AN EXTERNAL TUBE WAS NOT USED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. DATE OF INITIAL SURGERY WAS (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18108658 ↗
• MalfunctionNov 1, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH FUSION. IT WAS REPORTED THAT THE TIP OF THE IMPLANT INSERTER SHEARED OFF WITHIN THE IMPLANT. FRAGMENT WAS CONTAINED WITHIN THE IMPLANT, TIGHTLY SCREWED IN AND NOT REMOVABLE. THERE WAS A FRAGMENT OF THE IMPLANT REMAINING IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12726453 ↗
• MalfunctionNov 2, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT (MEDICAL HISTORY-DIABETES) HAVING PLIF (POSTERIOR LUMBAR INTERBODY FUSION) (LEVELS IMPLANTED -L3/L5) DUE TO LUMBAR CANAL STENOSIS (LCS). IT WAS REPORTED THAT AFTER THE CAGE WAS INSERTED, THE TIP OF THE INSERTER BROKE DUE TO A SLIGHT TWIST TO ADJUST THE POSITION. THE GRIP PART AT THE TIP WAS BROKEN. THE TIP OF THE INSERTER REMAINED ON THE GRIP PART OF THE CAGE. ALTHOUGH THE CAGE WAS ATTEMPTED TO BE REMOVED, IT WAS DIFFICULT, SO THE CAGE WAS LEFT AS IT WAS. THERE WERE NO PATIENT SYMPTOMS AS A RESULT OF THE EVENT. THE PRODUCT RETURN WAS REQUESTED. THERE WAS A PROCEDURAL DELAY OF LESS THAN 60 MINS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10769502 ↗
• MalfunctionNov 27, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR INTERBODY FUSION AT L3/4/5 DUE TO DEGENERATIVE SCOLIOSIS. INTRA-OP, THE CAGE WAS INSERTED FROM THE LEFT OF L4/5, WHILE BEING HAMMERED, PHYSICIAN CONFIRMED FROM THE PERSPECTIVE IMAGE THAT THE MARKER LOOKED DIFFERENT FROM USUAL. WHEN THE PHYSICIAN ATTEMPTED TO ADJUST THE MARKER TO BE REFLECTED ON THE TRUE SAGITTAL, THE INSERTER BROKE ALONG WITH A SNAP SOUND. NO FRAGMENT REMAINS IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8105006 ↗
• MalfunctionSep 6, 2018Break; Break

  PROCEDURE: TRANSFORAMINAL LUMBAR INTERBODY FUSION PRE-OPERATIVE DIAGNOSIS: LUMBAR SPINAL CANAL STENOSIS LEVEL: L4-S IT WAS REPORTED THAT INTRA-OP, BREAKAGE OF THE SHAFT WAS CONFIRMED OUTSIDE THE PATIENT'S BODY. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PRODUCT FRAGMENTS REMAINED IN PATIENT. NO SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7852230 ↗
• InjuryAug 9, 2017Break; Break

  IT WAS REPORTED THAT INTRA-OP, AFTER LOOSENING THE INSERTER SHAFT FROM THE CAGE THE PIN OF THE INSERTER WAS BROKEN. THE BROKEN PIN REMAINED IN THE CAGE. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6776211 ↗