CAPSTONE PTC™ Spinal System 3992209Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00643169187542), received between Nov 28, 2016 and Oct 9, 2023 — classified as 12 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryOct 9, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CAP STONE SPACER HAVING 2 INTERVERTEBRAL PLIF THERAPY PERFORMED ON 17 AUG AT L4-5-S1 FOR STENOSIS. IT WAS REPORTED THAT THE L4-5 PTC CAGE BACKED OUT. ON (B)(6), ADDITIONAL SURGERY WAS PERFORMED TO REMOVE THE 6 SCREWS AND DRIVE INTO THE L4-5 CAGE. THE SCREW WAS REPLACED WITH AN L2-3-4-5-S1-IL AND THE EXTENSION WAS FIXED. 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 17893798 ↗
• MalfunctionNov 16, 2021Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT THE SET SCREW BACKED OUT. THE L4 SCREW WAS ALSO A LITTLE LOOSE. AS THE BACK PAIN WORSENED, ADDITIONAL SURGERY PERFORMED TO REMOVE THE SCREWS AND REPLACE THEM. SINCE THERE WAS A POSSIBILITY THAT THE DORSAL SIDE OF THE LEFT CAGE THAT HAD BEEN PLACED WAS INTERFERING WITH THE NERVE ROOT, THE POSTERIOR DECOMPRESSION OF THE LEFT SIDE WAS ALSO PERFORMED ADDITIONALLY SINCE THE CAGE WAS SINKING. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THE ALLEGATION OF SCREW IS LOOSENESS. THERE WAS NO DEFECT WITH THE ROD.

  Patient problems: Pain

  MAUDE report 12818143 ↗
• MalfunctionJun 11, 2020Break; Break

  PRE-OPERATIVE DIAGNOSIS: SPINAL CANAL STENOSIS PROCEDURE PERFORMED: POSTERIOR LUMBAR INTERBODY FUSION (PLIF) LEVELS IMPLANTED: L2-5 INTRA-OP, WHEN THE INSERTER WAS ATTACHED TO PTC AND INSERTED INTO L3/4 OF THE SECOND INTERVERTEBRAL DISC SPACE THE ANGLE WAS MISALIGNED NEAR THE ENTRANCE OF THE INTERVERTEBRAL DISC SPACE SO WHEN IT WAS TAKEN OUT OF THE OPERATIVE FIELD, IT WAS IN A UNSTABLE STATE AND THE IMPLANT CAME OFF FROM THE HOLDER AND COULD NOT BE GRIPPED FIRMLY. THE THREAD OF CAGE MAY BE BROKEN. THE CAGE WAS INSERTED AGAIN NEAR THE ENTRANCE OF THE INTERVERTEBRAL DISC SPACE AND THEN IT WAS INSERTED USING AN INSERTION BAR. AFTER THAT THE INSERTER WAS REPLACED WITH ANOTHER ONE TO DEAL WITH THE OPERATION. THE ROTATE DISTRACTOR HAD ENTERED UP TO 9MM. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10141963 ↗
• InjuryOct 11, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) OF TWO INTERVERTEBRAL DISCS. POST-OP, THE CAGE BACKED OUT. AS A RESULT OF THIS PATIENT HAD UNDERWENT REVISION SURGERY ON (B)(6) 2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9178529 ↗
• InjuryMay 16, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH L5 SPONDYLOLYSIS; AND UNDERWENT L5-S1 POSTERIOR LUMBAR INTERBODY FUSION AND L4-S1 PERCUTANEOUS PEDICLE SCREW FIXATION. THE CAGE WAS INSERTED AFTER CURETTING THE INTERVERTEBRAL DISC. THE CAGE COULD ONLY BE INSERTED VERY CLOSE TO THE POSTERIOR WALL. THE PHYSICIAN CHECKED IF ADDITIONAL CURETTING WAS NEEDED ON THE ANTERIOR SIDE BUT FOUND THE CAGE'S POSITION TO BE GOOD ENOUGH. THEN INSERTION OF CAGE WAS PERFORMED ON THE CONTRALATERAL SIDE. WHEN INSERTING THE CAGE ON THE CONTRALATERAL SIDE, THE CAGE THAT WAS INSERTED BEFORE CAME OUT. THE PHYSICIAN HAMMERED THE CAGE AGAIN. THEN PPS AND COMPRESSION WAS PERFORMED. ALTHOUGH IT WAS SUSPECTED THAT THE CAGE BACKED OUT A LITTLE WHEN CHECKING THE SAGITTAL IMAGES, THE PHYSICIAN JUDGED IT WAS OKAY AND THE OPERATION WAS COMPLETED. IN THE POST-OPERATIVE CT, THE CAGE WAS FOUND BACKED-OUT. HENCE, THE WOUND WAS RE-OPENED AND REVISION SURGERY WAS PERFORMED TO REMOVE THE CAGE. AFTER REMOVING THE CAGE, BONE GRAFT WAS FILLED THERE AND OPERATION WAS COMPLETED AGAIN. THERE WAS A DELAY OF MORE THAN 60 MINUTES IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS WERE RE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8615192 ↗
• InjuryMar 29, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INITIAL SURGICAL PROCEDURE USED: L4/5 TRANSFORAMINAL LUMBAR INTERBODY FUSION(TLIF) PRE OPERATIVE DIAGNOSIS FOR THIS PROCEDURE(REVISION SURGERY): CAGE BACKED OUT TYPE OF PROCEDURE USED(REVISION SURGERY): CAGE REMOVAL LEVELS IMPLANTED: L4/5 IT WAS REPORTED THAT ON UNKNOWN DATE, POST-OP, CAGE BACKED OUT. PATIENT UNDERWENT REVISION SURGERY FOR CAGE REMOVAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8463270 ↗
• InjuryJan 21, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SPINAL CANAL STENOSIS AND UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION (PLIF) SURGERY AT L5-S1 LEVELS. POST-OPERATIVELY, THE LOWER EXTREMITY PAIN OCCURRED DUE TO CAGE BACKED OUT. AS A RESULT, REVISION SURGERY WAS PERFORMED AND THE CAGE WAS REMOVED FROM THE PATIENT AS BONE FUSION HAD NOT BEEN ACHIEVED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 8263526 ↗
• InjuryDec 5, 2018Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION AT L5-S1. POST-OP, THE CAGE BACKED OUT WHICH WAS REMOVED IN A REVISION SURGERY. PATIENT COMPLICATIONS OCCURRED AS NEUROLOGICAL SYMPTOM ATTRIBUTED TO BACKED OUT CAGE.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 8134859 ↗
• InjuryNov 30, 2018Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION (PLIF) OF L4-5, L5-S1 AND PEDICLE SCREW OF L3-S2AL. POST-OP, CAGE AT L5-S1 BACKED OUT. THE CAGE WAS REINSERTED AGAIN ON (B)(6) 2018 AS THE RESULT OF THE EVENT. PATIENT COMPLICATIONS REPORTED TO BE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8120459 ↗
• MalfunctionAug 30, 2018Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH DEGENERATIVE SPONDYLOLISTHESIS AT L4 AND UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION. POST-OP, AFTER 14 MONTHS CAGE SUBSIDENCE WAS CONFIRMED. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7831613 ↗
• InjuryJul 26, 2018Device Dislodged or Dislocated; Migration; Migration

  INITIAL SURGERY PROCEDURE: FIXATION WAS PERFORMED AT T10-S1 IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE CAGE AT THE RIGHT SIDE OF L5/S BACKED OUT. RE-OPERATION WAS PERFORMED FOR DECOMPRESSION AND FUSION FOR EXTENDING. DURING RE-OPERATION, S1 SCREW WAS REMOVED, S2AI SCREW WAS INSTALLED AND DECOMPRESSION WAS PERFORMED. THE BACKED OUT CAGE DID NOT MOVE AND FIXATION WAS PERFORMED AGAIN AT T10-S2A.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 7724526 ↗
• InjuryNov 17, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR FUSION SURGERY AT L4/5 AND TRANSFORAMINAL LUMBAR INTERBODY FUSION SURGERY AT L5/S USING CAGE. REPORTEDLY, POST-OP, THE CAGE BACKED OUT. HENCE, REVISION SURGERY WAS PERFORMED IN WHICH THE CAGE AT L5/S WAS REMOVED AND THEN ILIAC BONE WAS TRANSPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7040797 ↗
• InjuryAug 9, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT PRESENTED WITH PRE-OP DIAGNOSIS AS: LUMBAR CANAL STENOSIS. FOR WHICH PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT LEVELS L4/5/S. ON AN UNKNOWN DATE, POST-OP, THE CAGE AT L5/S BACKED OUT BACKED OUT. AS A RESULT, THE PATIENT REPORTED RIGHT L5 NERVE ROOT PAIN. HENCE, A RE-FIXATION SURGERY WAS PERFORMED AT L5-S TO RE-ADJUST THE BACKED OUT L5/S CAGE POSITION BY REPLACING S1 SCREW.

  Patient problems: No Code Available; Pain

  MAUDE report 6776473 ↗
• InjuryNov 28, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, CAGE AT L4/5 BACKED-OUT SLIGHTLY ABOVE THE POSTERIOR WALL. THE CAGE CAUSED NEUROLOGICAL SYMPTOM. REVISION SURGERY WAS PERFORMED.

  Patient problems: Neurological Deficit/Dysfunction; No Code Available

  MAUDE report 6128395 ↗
• InjuryNov 28, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, CAGE AT L4/5 BACKED-OUT SLIGHTLY ABOVE THE POSTERIOR WALL. THE CAGE CAUSED NEUROLOGICAL SYMPTOM. REVISION SURGERY WAS PERFORMED.

  Patient problems: Neurological Deficit/Dysfunction; No Code Available

  MAUDE report 6128392 ↗