CD HORIZON® Spinal System 55840006550Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00613994971760), received between Nov 30, 2017 and Nov 11, 2025 — classified as 16 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

1 other recall cover devices cleared under the same FDA submission (K113174); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CLINICAL ID: (B)(6), STUDY ID: (B)(4) AND SUBEVENT NUMBER: 1 IT WAS REPORTED THAT L4 SCREW IS LOOSE AT PRESENT THERE ARE NO SPECIAL TREATMENTS. CONTINUE TO OBSERVE AND AVOID PROLONGED BENDING AND WEIGHT-BEARING. DURING A ROUTINE VISIT, THE SUBJECT FOUND LOOSE SCREWS ON IMAGING, BUT THERE WERE NO REPORTS OF DISCOMFORT. GUIDE THE PARTICIPANT TO AVOID PROLONGED LUMBAR CURVATURE OR WEIGHTLIFTING. IF ANY DISCOMFORT ARISES, INFORM THE INVESTIGATOR AND RETURN TO THE SITE. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. UPDATED RECEIVED SITE ASSESSMENT: DD WITH SADE POTENTIAL = NO SPONSOR ASSESSMENT: DD WITH SADE POTENTIAL = NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23519813 ↗
• MalfunctionNov 11, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CLINICAL ID (B)(6), STUDY ID (B)(6) AND SUBEVENT NUMBER: 1 IT WAS REPORTED THAT L4 SCREW IS LOOSE AT PRESENT THERE ARE NO SPECIAL TREATMENTS. CONTINUE TO OBSERVE AND AVOID PROLONGED BENDING AND WEIGHT-BEARING. DURING A ROUTINE VISIT, THE SUBJECT FOUND LOOSE SCREWS ON IMAGING, BUT THERE WERE NO REPORTS OF DISCOMFORT. GUIDE THE PARTICIPANT TO AVOID PROLONGED LUMBAR CURVATURE OR WEIGHTLIFTING. IF ANY DISCOMFORT ARISES, INFORM THE INVESTIGATOR AND RETURN TO THE SITE. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. UPDATED RECEIVED SITE ASSESSMENT: DD WITH SADE POTENTIAL = NO SPONSOR ASSESSMENT: DD WITH SADE POTENTIAL = NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23519806 ↗
• MalfunctionJul 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A SCREW USED IN L5-S2 TLIF & POSTERIOR FUSION FOR MIS POSTERIOR REPEAT DECOMPRESSION AND REVISION INSTRUMENTATION FUSION AT L5-S1. LEVELS IMPLANTED: L5-S1. IT WAS REPORTED THAT AFTER THE RODS WERE REMOVED, ONE SCREW TULIP WAS STUCK IN A VERY AWKWARD POSITION. DUE TO THE ANGLE, THE DOCTOR HAD DIFFICULTIES GETTING HIS DRIVER INTO THE SCREW HEAD. HE USED A COUNTER TORQUE TO MOVE THE TULIP, AND APPLIED A SIGNIFICANT AMOUNT OF FORCE. AFTER REMOVING THE COUNTER TORQUE, IT WAS NOTED THAT THE TULIP HAD COME OFF THE SCREW SHANK. THE SHANK WAS ABLE TO BE REMOVED WITHOUT INCIDENT. THE TULIP/SHANK DO NOT APPEAR TO BE BROKEN, JUST SEPARATED FROM EACH OTHER. PATIENT SYMPTOMS ARE UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WERE NO PATIENT SYMPTOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19699765 ↗
• InjuryMay 14, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH 2 SCREWS IN AN OPEN SPONDYLODESIS AT L5/S1 FOR SPONDYLOLISTHESIS L5/S1. IT WAS REPORTED THAT POST-OP, A SCREW BROKE AND A REVISION SURGERY HAD TO BE DONE BECAUSE THE WHOLE CONSTRUCT BECAME LOOSE AND THE PATIENT WAS IN PAIN AS A RESULT. IN ADDITION, ANOTHER SCREW ALSO HAD A BREAK. THE BROKEN SCREWS NEEDED TO BE REPLACED BY OTHER ONES IN A REVISION SURGERY. THE REPORTED PRODUCTS AND THE PACKAGE LOOKED NORMALLY AS THEY SHOULD. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: Pain

  MAUDE report 19308245 ↗
• InjuryMay 14, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH 2 SCREWS IN AN OPEN SPONDYLODESIS AT L5/S1 FOR SPONDYLOLISTHESIS L5/S1. IT WAS REPORTED THAT POST-OP, A SCREW BROKE AND A REVISION SURGERY HAD TO BE DONE BECAUSE THE WHOLE CONSTRUCT BECAME LOOSE AND THE PATIENT WAS IN PAIN AS A RESULT. IN ADDITION, ANOTHER SCREW ALSO HAD A BREAK. THE BROKEN SCREWS NEEDED TO BE REPLACED BY OTHER ONES IN A REVISION SURGERY. THE REPORTED PRODUCTS AND THE PACKAGE LOOKED NORMALLY AS THEY SHOULD. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: Pain

  MAUDE report 19308238 ↗
• MalfunctionApr 12, 2024Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER, CLINICAL STUDY VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CLINICAL ID: (B)(6) AND STUDY ID: P16_03. MEDICAL HISTORY (POSITIVE RESPONSE): PREVIOUS LUMBAR SURGERY : SURGERY 1: DATE OF SURGERY: (B)(6) 2019 TYPE OF SPINAL SURGERY: DISCECTOMY, LAMINECTOMY, OTHER LEVEL(S): L3/L4 DETAILS: LEFT L3/L4 DISCECTOMY, LAMINECTOMY, <(>&<)> FACETECTOMY SURGERY 2: DATE OF SURGERY: (B)(6) 2012 TYPE OF SPINAL SURGERY: DISCECTOMY, LAMINECTOMY LEVEL(S): L4/L5 DETAILS: RIGHT L4-L5. PRIMARY DIAGNOSTIC INDICATION: ALL OTHER DIAGNOSTIC INDICATIONS: STENOSIS WITH DOCUMENTED PRE_OPERATIVE INSTABILITY, RECURRENT DISC HERNIATION. PLEASE INDICATE THE NUMBER OF CONSECUTIVE LEVELS (FROM L2- S1) THE SUBJECT WILL HAVE TREATED: 3 LEVELS. PATIENT IS A TOBACCO USE CURRENT USER. IT WAS REPORTED THAT ON POST OPERATIVE DAY 1, THE PATIENT EXPERIENCED RIGHT LATERAL THIGH NUMBNESS AS WELL AS "ACHY" RLE PAIN. PATIENT WAS STARTED ON SHORT COURSE OF DEXAMETHASONE, WHICH DID NOT SEEM TO ALLEVIATE HER RLE PAIN. PATIENT WAS DISCHARGED ON DEX 6MG. UPDATE (B)(6) 2022-PATIENT SEEN FOR SCHEDULED F/U VISIT- STILL CONTINUING AT THIS VISIT, RENEWED PRESCRIPTION FOR RABAXIN

  Patient problems: Numbness; Pain

  MAUDE report 19096302 ↗
• MalfunctionMar 25, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE SPINE SURGERY. IT WAS REPORTED THAT CT SCAN WAS DONE PER STUDY PROTOCOL AND SMALL AMOUNT OF LUCENCY ON THE S1 SCREWS. DOES NOT REPRESENT PSEUDARTHROSIS CURRENTLY. SHOULD REPEAT NON-STUDY CT IN 4MONTHS. SITE RELATED ASSESSMENT: POSSIBLE TO PLF GRAFTING MATERIAL, POSTERIOR FIXATION DEVICE AND SURGICAL PROCEDURE. RELATED TO SURGICAL CONSTRUCT AND/OR STUDY PROCEDURE. NOT RELATED TO INTERBODY FUSION DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18966893 ↗
• MalfunctionMar 25, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE SPINE SURGERY. IT WAS REPORTED THAT CT SCAN WAS DONE PER STUDY PROTOCOL AND SMALL AMOUNT OF LUCENCY ON THE S1 SCREWS. DOES NOT REPRESENT PSEUDARTHROSIS CURRENTLY. SHOULD REPEAT NON-STUDY CT IN 4MONTHS. SITE RELATED ASSESSMENT: POSSIBLE TO PLF GRAFTING MATERIAL, POSTERIOR FIXATION DEVICE AND SURGICAL PROCEDURE. RELATED TO SURGICAL CONSTRUCT AND/OR STUDY PROCEDURE. NOT RELATED TO INTERBODY FUSION DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18966868 ↗
• MalfunctionMar 25, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE SPINE SURGERY. IT WAS REPORTED THAT CT SCAN WAS DONE PER STUDY PROTOCOL AND SMALL AMOUNT OF LUCENCY ON THE S1 SCREWS. DOES NOT REPRESENT PSEUDARTHROSIS CURRENTLY. SHOULD REPEAT NON-STUDY CT IN 4MONTHS. SITE RELATED ASSESSMENT: POSSIBLE TO PLF GRAFTING MATERIAL, POSTERIOR FIXATION DEVICE AND SURGICAL PROCEDURE. RELATED TO SURGICAL CONSTRUCT AND/OR STUDY PROCEDURE. NOT RELATED TO INTERBODY FUSION DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18966854 ↗
• MalfunctionOct 31, 2023Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SACROILIAC AND THORACOLUMBAR (LOWER/MID SPINE) SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER SNAPPED IN TWO WHILE IMPLANTING SCREW BY HAND, SCREWS SEIZED UP WHEN THE DRIVER BROKE IN IT AND DRIVER SEIZED UP AND WILL NOT RATCHET IN EITHER DIRECTION. 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 18036495 ↗
• MalfunctionOct 31, 2023Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SACROILIAC AND THORACOLUMBAR (LOWER/MID SPINE) SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER SNAPPED IN TWO WHILE IMPLANTING SCREW BY HAND, SCREWS SEIZED UP WHEN THE DRIVER BROKE IN IT AND DRIVER SEIZED UP AND WILL NOT RATCHET IN EITHER DIRECTION. 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 18036488 ↗
• InjuryMar 16, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4-S1 AND L4-PE LVIS SPINAL FUSION. IT WAS REPORTED THAT THE SCREWS WERE BROKEN AND THE PART OF SCREW SHANK LEFT IN BONE. THE ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2023 FOR REVISION OF HARDWARE. THE DEVICE WAS PARTIALLY REMOVED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16551219 ↗
• InjuryDec 22, 2021Break; Break

  THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT AN OPERATION FOR RE-SPONDYLOSIS AND DIAGNOSIS OF LUMBAR DISC DEGENERATION AT L4-S1 FOR SPINAL THERAPY. IT WAS REPORTED THAT AFTER 3 MONTHS PATIENT HAD BACK PAIN. X-RAY SHOWED THAT BOTH S1 SCREWS WERE BROKEN. THERE WAS NO FURTHER INFORMATION REPORTED.

  Patient problems: Pain

  MAUDE report 13058283 ↗
• InjuryDec 15, 2021Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL FUSION AT L5 IN A PATIENT DIAGNOSED WITH SCOLIOSIS. IT WAS REPORTED THAT THE SCREW HEAD WAS BLOCKED. THE MAS FUNCTION OF THE SCREW HEAD WAS "COLD WELDED" TO THE TITANIUM SCREW BODY. THE OBLIQUE BLOCKED POSITION OF THE SCREW HEAD MADE IT IMPOSSIBLE TO PLACE THE SCREWDRIVER IN THE SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13007690 ↗
• InjuryJun 22, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A SPINAL PRODUCT TYPE FOR EARLIER FUSION MADE FROM TH11-L5. IT WAS REPORTED THAT SCREW WAS BROKEN AND THE THREADED PART REMAINS IN THE PATIENT AS IT COULDN¿T BE REMOVED. THE UPPER BODY WITH THE TULIP IS REMOVED. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER SYMPTOMS OR COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE EVENT DATE AND IMPLANT DATE IS UNKNOWN. THERE IS NO PLAN TO REMOVE THE BROKEN FRAGMENT LEFT INSIDE THE PATIENT. THE BROKEN PRODUCT WAS INITIALLY USED FOR THE FIRST SURGERY AND BROKE AFTER 1-1.5 YEARS IN THE PATIENT. NEED TO GET THE FIRST PROCEDURE DATE CONFIRMED. THEY NOTICED THE BROKEN SCREW WHEN THEY OPENED UP FOR THE EXTENSION. THE BROKEN TULIP WAS REMOVED AND IN THAT PEDICLE WHERE THE BROKEN SCREW SITS NOTHING WAS PUT IN AS REPLACEMENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12040001 ↗
• MalfunctionMay 17, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  UPDATED INFORMATION RECEIVED ON 25-MAY-2021: SPONSOR ASSESSMENT: EVENT IS UNLIKELY TO BE RELATED TO INFUSE KIT, MGS KIT , POSSIBLY RELATED TO MULTIAXIAL SCREWS, RODS, SET SCREWS AND NOT RELATED TO INTERBODY DEVICE, PROCEDURE AND SURGICAL PROCEDURE.

  Patient problems: Numbness

  MAUDE report 11830842 ↗
• InjuryMar 5, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT FUSION AT T11-ILIUM. POST-OP, ON (B)(6) 2019, THE PATIENT PRESENTED WITH ACUTE PAIN AND INFECTION; HENCE, THE WOUND WAS CLEANED AS THE PATIENT GOT KLEBSIELLA. NO IMPLANT OR INSTRUMENTATION WAS REMOVED IN THIS SURGERY. LATER, THE PATIENT AGAIN PRESENTED WITH PAIN; AND UNDERWENT A REVISION SURGERY ON (B)(6) 2019. ALLEGEDLY, THE TULIP OF THE REPORTED SCREW WAS FOUND LOCKED AT AN ANGLE. IN THIS REVISION SURGERY, ALL THE IMPLANTS WERE REMOVED AND CHANGED AS THE PATIENT HAD ENTEROCOCCUS; AND THE FUSION WAS EXTENDED FROM T11-ILIUM TO T11-S2.

  Patient problems: Unspecified Infection

  MAUDE report 9794864 ↗
• InjuryMar 5, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT FUSION AT T11-ILIUM. POST-OP, ON (B)(6) 2019, THE PATIENT PRESENTED WITH ACUTE PAIN AND INFECTION; HENCE, THE WOUND WAS CLEANED AS THE PATIENT GOT KLEBSIELLA. NO IMPLANT OR INSTRUMENTATION WAS REMOVED IN THIS SURGERY. LATER, THE PATIENT AGAIN PRESENTED WITH PAIN; AND UNDERWENT A REVISION SURGERY ON (B)(6) 2019. ALLEGEDLY, THE TULIP OF THE REPORTED SCREW WAS FOUND LOCKED AT AN ANGLE. IN THIS REVISION SURGERY, ALL THE IMPLANTS WERE REMOVED AND CHANGED AS THE PATIENT HAD ENTEROCOCCUS; AND THE FUSION WAS EXTENDED FROM T11-ILIUM TO T11-S2.

  Patient problems: Unspecified Infection

  MAUDE report 9794814 ↗
• InjuryDec 5, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT FUSION AT T11-ILIUM. POST-OP, ON (B)(6) 2019, THE PATIENT PRESENTED WITH ACUTE PAIN AND INFECTION; HENCE, THE WOUND WAS CLEANED AS THE PATIENT GOT KLEBSIELLA. NO IMPLANT OR INSTRUMENTATION WAS REMOVED IN THIS SURGERY. LATER, THE PATIENT AGAIN PRESENTED WITH PAIN; AND UNDERWENT A REVISION SURGERY ON (B)(6) 2019. ALLEGEDLY, THE TULIP OF THE REPORTED SCREW WAS FOUND LOCKED AT AN ANGLE. IN THIS REVISION SURGERY, ALL THE IMPLANTS WERE REMOVED AND CHANGED AS THE PATIENT HAD ENTEROCOCCUS; AND THE FUSION WAS EXTENDED FROM T11-ILIUM TO T11-S2.

  Patient problems: Unspecified Infection

  MAUDE report 9415228 ↗
• MalfunctionDec 5, 2019Mechanical Problem; Mechanical Problem

  THE INFECTION WAS IN THE WHOLE WOUND AND NOT AT A SPECIFIC LEVEL. THERE WERE MANY SCREWS THAT WERE EXPLANTED DURING THE REVISION SURGERY (DATED (B)(6) 2019); SOME OF WHICH, HAD LOCKED TULIPS.

  Patient problems: Unspecified Infection

  MAUDE report 9415207 ↗
• InjuryAug 6, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL FUSION SURGERY AT L5-S1 DUE TO DEGENERATIVE DISC DISEASE (DDD). POST-OP, THE SHAFT OF THE SCREW BROKE. PSEUDOARTHROSIS WAS REPORTED AS A RESULT OF THIS EVENT. PATIENT UNDERWENT REVISION SURGERY FOR THE REMOVAL OF BROKEN SCREW.

  Patient problems: Failure of Implant

  MAUDE report 8863604 ↗
• InjuryMar 11, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT FUSION SURGERY AT T10 AND T11 LEVELS. POST-OPERATIVELY, THE SET SCREWS SLIDE OUT OF SCREWS AND WERE EMBEDDED IN TISSUE. HENCE, A REVISION SURGERY WAS PERFORMED, WHEREIN THE SET SCREW WAS COMPLETELY EXPLANTED. T10 AND T11 WERE COMPLETELY FUSED AT TIME OF REVISION SURGERY. THE PATIENT ACHIEVED SOLID FUSION AND EXPERIENCED PAIN DUE TO THIS SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8406687 ↗
• InjuryMar 11, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT FUSION SURGERY AT T10 AND T11 LEVELS. POST-OPERATIVELY, THE SET SCREWS SLIDE OUT OF SCREWS AND WERE EMBEDDED IN TISSUE. HENCE, A REVISION SURGERY WAS PERFORMED, WHEREIN THE SET SCREW WAS COMPLETELY EXPLANTED. T10 AND T11 WERE COMPLETELY FUSED AT TIME OF REVISION SURGERY. THE PATIENT ACHIEVED SOLID FUSION AND EXPERIENCED PAIN DUE TO THIS SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8406680 ↗
• InjuryMar 11, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT FUSION SURGERY AT T10 AND T11 LEVELS. POST-OPERATIVELY, THE SET SCREWS SLIDED OUT OF SCREWS AND WERE EMBEDDED IN TISSUE. HENCE, A REVISION SURGERY WAS PERFORMED, WHEREIN THE SET SCREW WAS COMPLETELY EXPLANTED. T10 AND T11 WERE COMPLETELY FUSED AT TIME OF REVISION SURGERY. THE PATIENT ACHIEVED SOLID FUSION AND EXPERIENCED PAIN DUE TO THIS SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8406676 ↗
• InjuryMar 11, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT FUSION SURGERY AT T10 AND T11 LEVELS. POST-OPERATIVELY, THE SET SCREWS SLIDE OUT OF SCREWS AND WERE EMBEDDED IN TISSUE. HENCE, A REVISION SURGERY WAS PERFORMED, WHEREIN THE SET SCREW WAS COMPLETELY EXPLANTED. T10 AND T11 WERE COMPLETELY FUSED AT TIME OF REVISION SURGERY. THE PATIENT ACHIEVED SOLID FUSION AND EXPERIENCED PAIN DUE TO THIS SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8406671 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113174. One submission often covers many models, so check the product and lot details in each record.

• Z-2603-2018 · Jul 9, 2018 · Terminated
  Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.