Capstone Control PTC Spinal System 5011022Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169677500), received between Aug 17, 2018 and Aug 25, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4/5 POSTERIOR LUMBAR INTERBODY FUSION DUE TO LUMBAR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT THE LEFT CAGE WAS POSITIONED TOO INWARD, SO IT WAS DECIDED TO REMOVE AND REPOSITION THE CAGE. THE CAGE WAS SUCCESSFULLY REMOVED WITHOUT ANY ISSUES USING THE INSERTER, BUT UPON INSPECTION OF THE REMOVED CAGE, THE MARKER WAS FOUND TO BE PROTRUDING. 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 22888980 ↗
• MalfunctionMar 21, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR INTERBODY FUSION FOR LUMBAR CANAL STENOSIS (LCS). IT WAS REPORTED THAT DURING ROTATION,A MISALIGNMENT BETWEEN THE MARKER AND INSERTER WAS OBSERVED. AFTER REMOVAL, DEFORMATION OF THE CAGE WAS CONFIRMED. NO PATIENT SYMPTOMS WERE REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662039 ↗
• MalfunctionDec 31, 2024Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING L 4/5 PLIF PROCEDURE IN A PATIENT DIAGNOSED WITH LUMBAR HERNIA. IT WAS REPORTED THAT WHEN ATTEMPTING TO ATTACH THE SPECIFIED ITEM TO THE INSERTER, THE SCREW THREADS DID NOT MATCH AND IT COULD NOT BE ATTACHED. THE THREADS WHERE NOT EXPANDED, BUT RATHER THEY WERE SMALLER THAN USUAL. THERE IS NO VISIBLE DAMAGE TO THE THREADS, BUT CAN VISUALLY SEE SOMETHING LIKE A PEEK BURR. THE INSERTER IS NOT INCLUDED IN THE COMPLAINT AS IT HAD NO MALFUNCTION. 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 21046786 ↗
• MalfunctionJul 12, 2022Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT TRANSFOR AMINAL LUMBAR INTERBODY FUSION (TLIF) FOR POSTERIOR SPINAL FUSION DUE TO ADULT SPINAL DEFORMITY AND LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT THE DISTRACTOR WAS USED TO DISSECT UP TO 10 MM AND A THING OF THE SAME HEIGHT AS THE IMPLANT WAS USED IN THE TRIAL. FOR LEFT-SIDED PENETRATION, A 10 MM DISTRACTOR WAS VERTICALLY INSERTED AT THE RIGHT SIDE. THERE WAS RESISTANCE WHEN IT WAS ROTATED 90° IN THE INTERVERTEBRAL DISK, IT WAS ROTATED ON THE RIGHT SIDE USING THE LAMINA SPREADER. AFTER IT WAS ROTATED, THE SURGEON VISUALLY CONFIRMED THE DISTORTION OF THE CAGE. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14983941 ↗
• MalfunctionSep 1, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LUMBAR SPINAL CANAL STENOSIS AND L3-L4 SPONDYLOLISTHESIS. SHE UNDERWENT L3-L4 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AND L4-L5 POSTERIOR LUMBAR INTERBODY FUSION (PLIF). INTRA-OP, AFTER PERFORMING PLIF AT L4-L5, THE CAGE WAS FOUND DEVIATED FORWARD WHEN CHECKING THE SAGITTAL IMAGES. THE SURGEON THEN TRIED TO GRASP THE POSTERIOR SIDE OF THE CAGE WITH INSERTER¿S INNER CYLINDERS, PEAN AND KOCHER WHILE CHECKING THE SAGITTAL IMAGES; HOWEVER, THE CAGE ADVANCED FORWARD AND STOOD UPRIGHT IN THE ANTERIOR VERTEBRAL BODY. THE SURGEON JUDGED THAT IT WAS HARD TO REMOVE THE CAGE FROM THE POSTERIOR SIDE. HENCE, NEW CAGE WAS INSERTED AT THE INTERVERTEBRAL DISC SPACE AND COMPRESSION WAS APPLIED AND THE OPERATION WAS COMPLETED. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME DUE TO THIS EVENT. IT IS UNKNOWN IF THERE WERE ANY PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8952933 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LUMBAR CANAL STENOSIS; AND UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION AT L3-L4 AND TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-L5. ON AN UNKNOWN DATE, POST-OP, THE PATIENT HAD PSEUDOARTHROSIS AND THE PATIENT'S L4 VERTEBRAL BODY COLLAPSED. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY, IN WHICH ALL THE DEVICES PLACED AT L3-L4-L5 WERE ALL REMOVED. L4 VERTEBRECTOMY WAS PERFORMED AND T2 WAS PLACED. DIAMETER OF 22 × 25, AN ENDOCAP OF 8 DEGREE × 2 WERE PLACED ON THE CRANIOCAUDAL SIDE. PEDICLE SCREWS WERE INSERTED AT L2-L3 AND L5 WITH 5S FROM POSTERIOR SIDE, AND ROD WAS PLACED. CONNECTOR WAS PLACED AND THE PROCEDURE WAS COMPLETED.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 8947027 ↗
• MalfunctionMar 5, 2019Material Deformation; Material Deformation

  PRE-OPERATIVE DIAGNOSIS: LUMBAR SPINAL CANAL STENOSIS LEVEL IMPLANTED: L4-5 PROCEDURE: POSTERIOR LUMBAR INTERBODY FUSION (PLIF) IT WAS REPORTED THAT INTRA-OP, CAGE WAS PLACED IN THE INTERVERTEBRAL DISC SPACE AND ROTATED BUT THE CAGE DID NOT ROTATE SO IT WAS REMOVED. WHEN REMOVING THE HOLDER, SURGEON CHECKED THE IMAGE AND FOUND THAT THE SCREW ITSELF DID NOT ROTATE. SURGEON HURRIEDLY ATTACHED THE HANDLE AND REMOVED THE CAGE. THE REMOVED CAGE WAS DEFORMED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WAS A DELAY OF MORE THAN 60 MINUTES AS A RESULT OF THIS EVENT. PATIENT COMPLICATIONS WERE REPORTED UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8390502 ↗
• MalfunctionOct 17, 2018Material Deformation; Material Deformation

  IT REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH ADJACENT SEGMENT DISEASE AND UNDERWENT DECOMPRESSION AND FUSION FOR EXTENDING AT L5/S. DURING THE SURGERY, THE CAGE DEFORMED WHEN IT WAS ROTATED. THE CAGE WAS INSERTED TO INTERVERTEBRAL DISK WITH GRIPPING IMPLANT HOLDER AND THE CAGE WAS ROTATED. THE REPORTED PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7976222 ↗
• MalfunctionSep 26, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT L3/4 TLIF (TRANSFEROMINAL LUMBAR INTERBODY FUSION) DUE TO LUMBAR SPINAL CANAL STENOSIS. INTRA-OP, LOOSENING HAPPENED TO THE PART BETWEEN THE INSERTER AND THE CAGE. DURING CAGE INSERTION, WHEN INSERTER WAS HAMMERED BY HAMMER, IT WAS DIFFICULT FOR THE CAGE TO ENTER AND WHEN IT WAS REMOVED OUT OF THE OPERATIVE FIELD. WHEN CONFIRMING, IT WAS FOUND THAT THE CAGE GOT LOOSE FROM THE INSERTER BECAUSE THE THREADED PART SEEMED TO BE BROKEN, A NEW ONE WAS OPENED TO DEAL WITH IT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7909291 ↗
• MalfunctionAug 17, 2018Break; Break

  PRE-OPERATIVE DIAGNOSIS: DEGENERATIVE SPONDYLOLISTHESIS PROCEDURE: TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) LEVELS: L5-S1 IT WAS REPORTED THAT INTRA-OP, THE CAGE BROKE WHEN BEING ROTATED AT THE TIME OF CAGE INSERTION AND IT WAS CONSIDERED THAT IT WAS BECAUSE THE BONE WAS HARD. THERE WAS A DELAY OF LESS THAN 60 MIN. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7794553 ↗