CAPSTONE PTC™ Spinal System 3992207Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169187566), received between Dec 28, 2017 and Apr 8, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH 'LCD'; AND UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION AT L3-L5. INTRA-OP, THE THREADED PART OF THE CAGE, WHICH WAS USED TO CONNECT WITH THE INSERTER, STRIPPED AND THE CAGE COULD NOT BE ATTACHED TO THE INSERTER. WHEN THE CAGE WAS HAMMERED IN, THE CAGE DID NOT ENTER THE INTERVERTEBRAL DISC SPACE FULLY, AND THE THREADED PART LOOSENED. THE CAGE WAS TAKEN OUT AND AN ATTEMPT WAS MADE TO ATTACH THE CAGE TO THE INSERTER AGAIN OUTSIDE THE OPERATIVE FIELD, BUT THE THREADED PART WAS FOUND WIDENED AND THE CAGE COULD NOT BE ATTACHED TO THE INSERTER. THE CAGE WAS REPLACED WITH A NEW CAGE, BUT THE NEW CAGE WAS PLACED AS IF IT WAS PUSHED IN FORCIBLY. SINCE THE IMAGES AND RADIOGRAPHS WERE NOT CHECKED DURING OPERATION, IT WAS CHECKED AFTER THE OPERATION, WHICH FOUND THAT THE TIP OF THE SCREW MAY HAVE RUPTURED INTO THE INTERVERTEBRAL DISC SPACE. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO FRAGMENT OF THE STRIPPED IMPLANT REMAINED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Rupture

  MAUDE report 9934298 ↗
• MalfunctionFeb 17, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION AT L5-S1 DUE TO DEGENERATIVE SCOLIOSIS. INTRA-OP, A CAGE BACKED OUT TO THE FORWARD DIRECTION. TWO CAGES WERE INSERTED; AND THE FIRST CAGE WAS PUSHED BY THE SECOND INSERTED CAGE. THE FIRST CAGE COMPLETELY BACKED OUT TO THE FORWARD DIRECTION. THIS CAGE PROTRUDED FORWARD OF THE VERTEBRAL BODY. THE SURGEON TRIED TO REMOVE THE CAGE BY PERFORMING A PROCEDURE FROM THE FRONT; BUT HE FAILED AND GAVE UP THE REMOVAL OF CAGE. THE WOUND CLOSURE WAS PERFORMED WITH CAGE STILL REMAINING IN THE PATIENT. THERE WAS A DELAY OF MORE THAN 60 MINUTES IN OVERALL PROCEDURE TIME. ACCORDING TO THE REP, THIS EVENT OCCURRED DUE TO TECHNICAL ERROR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED CURRENTLY. THE PATIENT IS UNDER FOLLOW-UP OBSERVATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8346487 ↗
• MalfunctionDec 28, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION AT L2/5 DUE TO LUMBAR SPINAL CANAL STENOSIS. INTRA-OPERATIVELY, THE CAGE BROKE ON INSERTION INTO L3/4 WHEN IT WAS STRUCK TWO OR THREE TIMES. THE UPPER SURFACE OF THE CAGE BROKE WHEN ABOUT HALF OF THE CAGE WAS INSERTED TO THE INTERVERTEBRAL SPACE. THE BROKEN PART WAS REMOVED AND THE SURGERY WAS CONTINUED WITH ANOTHER CAGE AFTER CONFIRMING NO FRAGMENTS IN THE BODY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7150440 ↗