CAPSTONE PTC™ Spinal System 3992210Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169187535), received between Jan 2, 2017 and Jun 30, 2026 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM CLINICAL STUDY, HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CLINICAL ID (B)(6), AND STUDY ID - (B)(6). IT WAS REPORTED THAT DURING MMI IMAGING ANALYSIS, HARDWARE LOOSENING WAS OBSERVED. PATIENT WAS TREATED FOR 2 LEVELS. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO REVISION SURGERY PLANNED OR SCHEDULED FOR THE REMOVAL OF IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25662304 ↗
• InjuryMar 11, 2025Migration; Migration

  SPONSOR ASSESSMENT: CEC ADJUDICATED AS CAUSAL RELATED TO TLIF PROCEDURE, AND POSSIBLE TO TLIF GRAFTING MATERIAL, INTER BODY FUSION DEVICE, AND POSTERIOR SUPPLEMENTAL FIXATION SYSTEM.

  Patient problems: Back pain; Bone Fracture(s); Intervertebral Disc Compression or Protrusion

  MAUDE report 21569924 ↗
• InjuryOct 25, 2019Migration; Migration

  PATIENT DEMOGRAPHICS: GENDER- MALE, AGE (AT THE TIME OF EVENT)- (B)(6) YEARS. PROCEDURE: IMPLANT DATE: (B)(6) 2019, EXPLANT DATE: (B)(6) 2019 IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION AT L3-S1 DUE TO UNKNOWN REASONS. POST-OPERATIVELY, THE CAGE IMPLANTED AT L5-S1 BACKED OUT. THE PATIENT EXPERIENCED PAIN LOWER EXTREMITY PAIN AT L5-S1. HENCE, A REVISION SURGERY WAS PERFORMED IN WHICH THE CAGE WAS EXPLANTED AND FUSION FOR EXTENDING WAS PERFORMED TO THE SCREW ON THE RIGHT SIDE OF S2. RE-FIXATION OF L3-4-5-S1-S2 WAS PERFORMED ONLY ON THE RIGHT SIDE.

  Patient problems: Pain

  MAUDE report 9241122 ↗
• MalfunctionMay 20, 2019Break; Break

  THE PATIENT WAS PRESENTED WITH G1 DEGENERATIVE SPONDYLOLISTHESIS AND UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION (PLIF) AT L4/5. INTRA-OP, AFTER THE CAGE INSERTION ON THE RIGHT OF L4/5, THE DEFECTIVE CAGE WAS HAMMERED WITH A PLASTIC HAMMER ON THE LEFT. AFTER HAMMERED FOR A WHILE, THE POSTERIOR BORDER OF THE CAGE PROTRUDED ABOUT 5 MM TO THE L4 VERTEBRAL POSTERIOR WALL WHICH HAD SPONDYLOLISTHESIS, SO THE PHYSICIAN DETERMINED TO HAMMER THE CAGE IN ADDITIONALLY WITH A METAL HAMMER. THEN, ABOUT 5MM SEPARATED FROM THE POSTERIOR BORDER OF THE CAGE, AND THE BROKEN PART OF THE CAGE CAME OFF TOGETHER WITH THE GRIPPING PART OF STANDARD INSERTER. AFTER THAT, THE REMAINING PART OF THE CAGE WAS REMOVED WITH INSTRUMENTS NEW CAGE OF 1MM SMALLER WAS INSERTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8623107 ↗
• 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 7831617 ↗
• InjuryJul 11, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L4-5. IN THE SURGERY 2 CAGES WERE IMPLANTED. THE REAR PART OF ONE OF THE CAGES WAS PLACED AT THE SAME POSITION AS THE POSTERIOR WALL AT L5. THE SURGERY WAS PERFORMED WITHOUT PROBLEM. HOWEVER, POSTOPERATIVELY, THE CAGE PLACED AT THE SAME POSITION WITH POSTERIOR WALL AT L5 WAS FOUND TO BE BACKED-OUT EXCESSIVELY. CAUDA EQUINE WAS PRESSURED BY THE BACKED-OUT CAGE WHICH CAUSED PAIN. THE PATIENT SUFFERED DISABILITY DUE TO THIS EVENT. ONLY ONE CAGE WAS BACKED OUT BUT IT IS UNKNOWN WHICH ONE BACKED OUT.

  Patient problems: Disability; No Code Available; Pain

  MAUDE report 6700102 ↗
• InjuryJun 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION DUE TO L4 SPONDYLOLISTHESIS DURING WHICH CAGES WERE IMPLANTED. POST-OP, INFECTION OF THE INTER-VERTEBRAL DISC WAS OBSERVED. A REVISION SURGERY HAS BEEN PLANNED FOR THE REMOVAL OF THE CAGE DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 6662717 ↗
• InjuryJan 2, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT PATIENT WITH LUMBAR SPINAL CANAL STENOSIS UNDERWENT L4/5 POSTERIOR LUMBAR INTERBODY FUSION USING CAGES AT BOTH SIDES OF L4/5. POST-OP,ON (B)(6) 2016, PATIENT COMPLAINED OF PAIN AND IMAGE WAS TAKEN WHICH SHOWED BACKED OUT CAGE. IT WAS COMPLETELY BACKED OUT AT RIGHT SIDE. A CAGE AT LEFT SIDE SEEMED TO MOVE TOO. NUMBNESS HAS BEEN OBSERVED IN THE PATIENT. THE PATIENT WAS HOSPITALIZED(MIGHT BE DUE TO GASTROENTEROLOGY) FOR DUODENAL ULCER AFTER PLIF SURGERY. CAGE REMOVAL SURGERY IS SCHEDULED ON (B)(6).THE SURGEON CONSIDERED THAT THE COMPRESSION MIGHT HAVE NOT BEEN APPLIED ENOUGH OR THE CAGE¿S SIZE MIGHT HAVE BEEN SMALL OR FACET MIGHT HAVE PREVENTED COMPRESSION.

  Patient problems: No Code Available; Numbness; Pain

  MAUDE report 6217038 ↗