Capstone Control PTC Spinal System 5011222Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169677524), received between Feb 25, 2019 and Feb 14, 2022 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 14, 2022Migration; Migration

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING USE OF THE REPORTED PRODUCTS. THE PRE-OP DIAGNOSIS WAS MENTIONED AS L4 / 5 CAGE MOVEMENT. IT WAS REPORTED THAT, L4 / 5PLIF FUSION IN THE CASE OF RE-DECOMPRESSION WAS PERFORMED ON (B)(6) 2021. L4/L5 CAGE MOVEMENT WAS SEEN DURING FOLLOW-UP. THERE WAS LOOSENESS OF SCREW ALSO REPORTED. THE L4/L5 SCREW WAS REMOVED, AND SCREWS WERE PLACED AGAIN INTO L3/4/5/S. CAGE WAS INSERTED AGAIN DURING RE-OPERATION. REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 AND THE CAGES WERE RE-INSERTED. THE LOOSENESS OF SCREW WAS IDENTIFIED DURING THE REVISION SURGERY. THE CAGES WERE IMPLANTED AND REMAINS IN SERVICE AND THE SCREWS, ROD WERE EXPLANTED ¿ COMPLETE. THERE WERE NO PATIENT SYMPTOMS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13522679 ↗
• InjuryFeb 14, 2022Migration; Migration

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING USE OF THE REPORTED PRODUCTS. THE PRE-OP DIAGNOSIS WAS MENTIONED AS L4 / 5 CAGE MOVEMENT. IT WAS REPORTED THAT, L4 / 5PLIF FUSION IN THE CASE OF RE-DECOMPRESSION WAS PERFORMED ON (B)(6) 2021. L4/L5 CAGE MOVEMENT WAS SEEN DURING FOLLOW-UP. THERE WAS LOOSENESS OF SCREW ALSO REPORTED. THE L4/L5 SCREW WAS REMOVED, AND SCREWS WERE PLACED AGAIN INTO L3/4/5/S. CAGE WAS INSERTED AGAIN DURING RE-OPERATION. REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 AND THE CAGES WERE RE-INSERTED. THE LOOSENESS OF SCREW WAS IDENTIFIED DURING THE REVISION SURGERY. THE CAGES WERE IMPLANTED AND REMAINS IN SERVICE AND THE SCREWS, ROD WERE EXPLANTED COMPLETE. THERE WERE NO PATIENT SYMPTOMS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13522621 ↗
• InjuryJul 3, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SPINAL CANAL STENOSIS; AND UNDERWENT A SURGERY. ON AN UNKNOWN DATE, POST-OP, THE ALLEGED CAGE BACKED-OUT BETWEEN L4 AND L5. ADDITIONALLY, A TOTAL OF 5 SCREWS LOOSENED AT THE FOLLOWING LOCATIONS: L5 LEFT, L5 RIGHT, L2 LEFT, L2 RIGHT AND L4 LEFT. HENCE, A REVISION SURGERY WAS PERFORMED, IN WHICH ALL THE 5 LOOSENED SCREWS WERE REPLACED WITH NEW ONES AND THE BACKED-OUT CAGE WAS REPLACED WITH AUTOGENOUS BONE GRAFT. IN ADDITION, FIXATION WAS PERFORMED AT S1 AND S2AI WITH SCREWS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10230716 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POST-OP, PATIENT GOT INFECTED AND AS A RESULT OF THIS UNDERWENT REVISION SURGERY IN WHICH IMPLANTED CAGE AND SCREW WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 9697548 ↗
• MalfunctionNov 15, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION (PLIF) AT L5/S1 DUE TO LUMBAR CANAL STENOSIS. INTRA-OP, WHEN THE INSERTER WHICH WAS ATTACHED TO THE CAGE WAS INSERTED INTO THE INTERVERTEBRAL SPACE WITH A HAMMER (BEFORE ROTATING), IT WAS FOUND THAT THE SCREW OF THE INSERTER HAD LOOSENED. THE SCREW WAS TURNED AGAIN, BUT THE CAGE COULD NOT BE FIXED ONTO THE INSERTER AT ALL. THERE WERE DAMAGES AND DEFORMATION FOUND POST-OPERATIVELY ON THE CAGE THAT MUST HAD BEEN GENERATED DURING THE REMOVAL. SO THE CAGE WAS ONCE REMOVED AND ANOTHER CAGE WAS ATTACHED TO THE INSERTER. THE INTERVERTEBRAL DISC SPACE WAS NARROW AND IT SEEMS HAMMERING WAS MORE THAN USUAL. AS REPORTED IN THE OVERALL PROCEDURE WAS DELAYED BY LESS THAN 60 MINS. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9325787 ↗
• InjuryMar 8, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION (PLIF) OF 2 INTERVERTEBRAL DISCS AT L4/5/S DUE TO OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES AND LUMBAR SPINAL CANAL STENOSIS. POST-OP, THE CAGE PLACED AT L5/S ROTATED IN THE INTERVERTEBRAL DISC SPACE. THE PATIENT SUFFERED FROM PSEUDOARTHROSIS AND LOWER BACK PAIN. PATIENT UNDERWENT REVISION SURGERY FOR THE REMOVAL OF IMPLANT AND FOR EXTENSION OF FUSION.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8402647 ↗
• InjuryFeb 25, 2019Migration; Migration

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: SPINAL CANAL STENOSIS PROCEDURE OR TECHNIQUE USED: POSTERIOR LUMBAR INTERBODY FUSION LEVELS IMPLANTED: L4-5 IT WAS REPORTED THAT POST-OP, CAGE AT L4-5 BACKED OUT. PATIENT HAD NERVE ROOT SYMPTOMS ATTRIBUTED TO CAGE BACK OUT.

  Patient problems: Nerve Damage

  MAUDE report 8367929 ↗