CD HORIZON® Spinal System 55840007545Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00643169004344), received between Dec 1, 2017 and Jan 7, 2026 — classified as 8 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (9 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CLINICAL ID (B)(6) PSEUDARTHROSIS WITH SCREW LOOSENING IN THE LUMBAR SPINE. ONSET 01 DEC 2025 (POST-SURGERY). CT ON 21 NOV 2025 SHOWED SCREW LOOSENING AT THE SUPERIOR AND INFERIOR ENDS OF THE LUMBAR CONSTRUCT; MARKED CLINICALLY SIGNIFICANT. SITE AWARENESS DATE 10 DEC 2025. INTERVENTIONS/OUTCOME: NO HOSPITALIZATION AND NO TREATMENT TAKEN FOR THE AE AT THE TIME OF REPORTING; REFERRAL TO NEUROSURGERY AND REPEAT CT UNDER CONSIDERATION. OUTCOME STATUS NOT RECOVERED/NOT RESOLVED (NO OUTCOME DATE PROVIDED). SEVERITY NOT REPORTED. RELATEDNESS: STUDY DEVICE NOT RELATED; PROCEDURE (INDEX SURGERY) PROBABLE. MEDICAL HISTORY: ANKYLOSING SPONDYLITIS, HYPERTENSION, PSORIATIC ARTHRITIS.. 2025 DEC 18, UPDATE RECEIVED SITE RELATED ASSESSMENT: PROBABLY RELATED TO STUDY DEVICE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 23991949 ↗
• MalfunctionOct 17, 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). ON (B)(6) 2025, A CT (DIAGNOSTIC) REPORTED ABNORMAL FINDINGS WITH HALOING AROUND THE L2 AND PELVIC SCREWS CONSISTENT WITH SCREW LOOSENING, WITH PELVIS INSTRUMENTATION IN PLACE AND EARLY PARTIAL FUSION NOTED. THE PATIENT HAS A HISTORY OF LUMBAR SURGERY (LAMINECTOMIES IN 1999 AND 2000 AT L4/L5¿L5/S1). THE PRIMARY DIAGNOSTIC INDICATION WAS STENOSIS WITH DOCUMENTED PRE-OPERATIVE INSTABILITY, WITH FOUR CONSECUTIVE LEVELS (L2¿S1) TREATED. SITE ASSESSMENT INDICATED A CAUSAL RELATIONSHIP TO THE INTERBODY FUSION DEVICE, POSTERIOR FIXATION DEVICE, PLF GRAFTING MATERIAL, AND THE SURGICAL CONSTRUCT/PROCEDURE. SPONSOR ASSESSMENT CONCLUDED THE EVENT IS CAUSALLY RELATED TO THE POSTERIOR FIXATION DEVICE AND NOT RELATED TO THE PROCEDURE, PLF GRAFTING MATERIAL, OR THE INTERBODY DEVICE. NO ADDITIONAL CLINICAL SYMPTOMS OR COMPLICATIONS WERE PROVIDED IN THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23322049 ↗
• MalfunctionOct 17, 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). ON (B)(6) 2025, A CT (DIAGNOSTIC) REPORTED ABNORMAL FINDINGS WITH HALOING AROUND THE L2 AND PELVIC SCREWS CONSISTENT WITH SCREW LOOSENING, WITH PELVIS INSTRUMENTATION IN PLACE AND EARLY PARTIAL FUSION NOTED. THE PATIENT HAS A HISTORY OF LUMBAR SURGERY (LAMINECTOMIES IN 1999 AND 2000 AT L4/L5¿L5/S1). THE PRIMARY DIAGNOSTIC INDICATION WAS STENOSIS WITH DOCUMENTED PRE-OPERATIVE INSTABILITY, WITH FOUR CONSECUTIVE LEVELS (L2¿S1) TREATED. SITE ASSESSMENT INDICATED A CAUSAL RELATIONSHIP TO THE INTERBODY FUSION DEVICE, POSTERIOR FIXATION DEVICE, PLF GRAFTING MATERIAL, AND THE SURGICAL CONSTRUCT/PROCEDURE. SPONSOR ASSESSMENT CONCLUDED THE EVENT IS CAUSALLY RELATED TO THE POSTERIOR FIXATION DEVICE AND NOT RELATED TO THE PROCEDURE, PLF GRAFTING MATERIAL, OR THE INTERBODY DEVICE. NO ADDITIONAL CLINICAL SYMPTOMS OR COMPLICATIONS WERE PROVIDED IN THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23321955 ↗
• MalfunctionMay 29, 2025Degraded; Degraded

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST AN UNKNOWN L4-S1 SPINAL PROCEDURE IN A PATIENT DIAGNOSED WITH LUMBAR STENOSIS. IT WAS REPORTED THAT THE ROD WAS BROKEN POST SURGERY. PATIENT HAD PAIN AND PSEUDOARTHROSIS. THE ROD WAS EXPLANTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 22103618 ↗
• MalfunctionJan 30, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL INFORMATION RECEIVED: COMMENTS: RIGHT L3 PEDICLE SCREW WAS LOOSENING AND SUBSIDENCE AT THE L3-4 LEVEL NOTED ON THE 12 MONTH CT SCAN. RELATED TO TLIF GRAFTING MATERIAL, "SUBSIDENCE IS MENTIONED IN ADDITION TO SCREW LOOSENING. SITE RELATED ASSESSMENT: POSSIBLY RELATED TO CAPSTONE PEEK SPINAL SYSTEM IMPLANT AND TLIF GRAFTING MATERIAL, CAUSAL RELATIONSHIP TO POSTERIOR SUPPLEMENTAL FIXATION SYSTEM AND DEVICE HARDWARE - INDEX SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21271491 ↗
• InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE STATING THE TARGET LEVELS WERE L4/L5 AND L5/S1. INVESTIGATOR ASSESSMENT STATES, THE ADVERSE EVENT WAS RELATED TO PROCEDURE/DEVICE. POSSIBLE RELATED TO PROCEDURE, POSTERIOR LUMBAR FUSION GRAFTING MATERIAL, POSTERIOR FIXATION AND INTERBODY FUSION. SPONSOR ASSESSMENT STATES, POSSIBLY RELATED TO POSTERIOR LUMBAR FUSION GRAFTING MATERIAL, POSTERIOR FIXATION, INTERBODY FUSION AND NOT RELATED TO SURGICAL FUSION. SPONSOR ASSESSMENT (OC MUO): CEC ASSESSMENT - CAUSAL RELATED TO THE PROCEDURE. POSSIBLE RELATIONSHIP TO POSTERIOR LUMBAR FUSION GRAFTING, POSTERIOR FIXATION AND INTERBODY FUSION. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21046316 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE PATIENT HAD LOWER INSTRUMENTED BODY FRACTURE (CORONAL SPLIT FRACTURE) L5, FIRST NOTED ON X-RAY ON (B)(6) -2024 AND CONFIRMED WITH CT ON (B)(6) 2024 AND MRI ON (B)(6) 2024. DIAGNOSTIC TEST: X-RAY. DIAGNOSTIC TEST DATE: 26-APR-2024. THE AE RESULT IN THE PROLONGATION OF AN EXISTING HOSPITALIZATION. START DATE OF THE HOSPITALIZATION: (B)(6) 2024. END DATE OF THE HOSPITALIZATION: (B)(6) 2024. THE OUTCOME OF THIS AE: RECOVERING/RESOLVING. THE AE RESULT IN ANY TREATMENT: NO. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 20493840 ↗
• InjuryApr 18, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER, REGULATORY BODY VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED PRODUCTS. IT WAS REPORTED THAT, SPINAL RODS WERE BROKEN AT L4/L5 AND SCREWS WERE LOOSE AT L5/S1. REVISION SURGERY WAS PERFORMED TO EXPLANT THE BROKEN RODS. LOOSE SCREWS EXPLANTED DURING REVISION SURGERY. THERE WERE NO PATIENT SYMPTOMS REPORTED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19133344 ↗
• 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 18966911 ↗
• 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 18966908 ↗
• MalfunctionMar 20, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION RECEIVED FROM CLINICAL STUDY, HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF A PATIENT WITH CLINICAL PATIENT ID (B)(6) , STUDY ID (B)(6). EVENT: IT WAS REPORTED THAT, ON (B)(6) 2023 PATIENT REPORTED NEW LEFT BUTTOCK PAIN THAT STARTED ABOUT 2 MONTHS AGO, REPORTS THAT PAIN IS ACHY AND RUNS DOWN LEFT LOWER EXTREMITY (LLE). SITE RELATED ASSESSMENT: POSSIBLY RELATED TO INTERBODY FUSION, POSTERIOR FIXATION AND SURGICAL PROCEDURE. NOT RELATED TO PLF GRAFTING MATERIAL AND RELATED TO SURGICAL CONSTRUCT AND/OR STUDY PROCEDURE. SPONSOR ASSESSMENT: YES DESCRIPTION: LEFT BUTTOCK PAIN WITH RADIATION. ONSET DATE: (B)(6) 2023. DIAGNOSTICS: ACTION TYPE: DIAGNOSTIC ACTION SUB-TYPE : L-SPINE 4 VW-1 ACTION DATE : (B)(6) 2023. INTERVENTIONS : ACTION SUBTYPE : OTHER ACTION RESULT: Y- FILM CONFERENCE TO REVIEW/READ STUDY CT FROM (B)(6) 2023. SHOULD AVOID BENDING AT BACK & BEND FROM THE KNEES TO AVOID BACK INJURY, SHOULD HOLD OFF ON ACTIVITIES SUCH AS KAYAKING UNTIL RADIOLOGIST READS CT. ADDITIONAL INFORMATION RECEIVED ON 2024-FEB-29: ACTION TYPE: DIAGNOSTIC ACTION SUBTYPE: L-SPINE 4 VW-1 ACTION RESULT: NORMAL ACTION DATE: (B)(6) 2023 ACTION T

  Patient problems: Pain

  MAUDE report 18939012 ↗
• MalfunctionMar 20, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION RECEIVED FROM CLINICAL STUDY, HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF A PATIENT WITH CLINICAL PATIENT ID (B)(6), STUDY ID (B)(6). EVENT: IT WAS REPORTED THAT, ON (B)(6) 2023 PATIENT REPORTED NEW LEFT BUTTOCK PAIN THAT STARTED ABOUT 2 MONTHS AGO, REPORTS THAT PAIN IS ACHY AND RUNS DOWN LEFT LOWER EXTREMITY (LLE). SITE RELATED ASSESSMENT: POSSIBLY RELATED TO INTERBODY FUSION, POSTERIOR FIXATION AND SURGICAL PROCEDURE. NOT RELATED TO PLF GRAFTING MATERIAL AND RELATED TO SURGICAL CONSTRUCT AND/OR STUDY PROCEDURE. SPONSOR ASSESSMENT: YES DESCRIPTION: LEFT BUTTOCK PAIN WITH RADIATION. ONSET DATE: (B)(6) 2023, DIAGNOSTICS: ACTION TYPE: DIAGNOSTIC ACTION SUB-TYPE : L-SPINE 4 VW-1 ACTION DATE : (B)(6) 2023, INTERVENTIONS : ACTION SUBTYPE : OTHER ACTION RESULT: Y- FILM CONFERENCE TO REVIEW/READ STUDY CT FROM (B)(6) 2023. SHOULD AVOID BENDING AT BACK <(>&<)> BEND FROM THE KNEES TO AVOID BACK INJURY, SHOULD HOLD OFF ON ACTIVITIES SUCH AS KAYAKING UNTIL RADIOLOGIST READS CT. ADDITIONAL INFORMATION RECEIVED ON 2024-FEB-29: ACTION TYPE: DIAGNOSTIC ACTION SUBTYPE: L-SPINE 4 VW-1 ACTION RESULT: NORMAL ACTION DATE: 2023-07-31, AC

  Patient problems: Pain

  MAUDE report 18938979 ↗
• MalfunctionFeb 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED THAT THE LOOSENING OF THE IMPLANT WAS CAUSED BY THE FALL AND NOT BECAUSE OF A PRODUCT. WHILE THIS DOSE INVOLVED THE SURGICAL SCREWS, BUT THE CAUSE OF THE AE WAS THE FALL. INVESTIGATOR¿S ASSESSMENT OF NOT RELATED TO SURGICAL CONSTRUCT AND/OR STUDY PROCEDURE. ALSO, THE SPONSOR HAS UPDATED ASSESSMENT TO NOT RELATED TO CONSTRUCT/STUDY PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695425 ↗
• InjurySep 14, 2022Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER, CLINICAL STUDY VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CLINICAL ID: (B)(6) AND STUDY ID: (B6). MEDICAL HISTORY (POSITIVE RESPONSE): SURGERY 1: DATE OF SURGERY: (B)(6) 2016 TYPE OF SPINAL SURGERY: DISCECTOMY LEVEL(S): L4/L5 DETAILS: MICRODISCECTOMY SURGERY 2: DATE OF SURGERY: (B)(6) 2016 TYPE OF SPINAL SURGERY: OTHER LEVEL(S): L4/L5 DETAILS: MEDIAL FACETECTOMY SURGERY 3: DATE OF SURGERY: (B)(6) 2016 TYPE OF SPINAL SURGERY: FORAMINOTOMY LEVEL(S): L4/L5 DETAILS: FORAMINOTOMY FOR RECURRENT HERNIATED DISC SURGERY 4: DATE OF SURGERY: (B)(6) 2016 TYPE OF SPINAL SURGERY: DISCECTOMY LEVEL(S): L4/L5 DETAILS: REVISION OF MICRODISCECTOMY SURGERY 5: DATE OF SURGERY: (B)(6) 2016 TYPE OF SPINAL SURGERY: OTHER LEVEL(S): L4/L5 DETAILS: REVISION OF MEDIAL FACETECTOMY SURGERY 6: DATE OF SURGERY: (B)(6) 2016 TYPE OF SPINAL SURGERY: FORAMINOTOMY LEVEL(S): L4/L5 DETAILS: REVISION. DESCRIBE THE ADDITIONAL SURGICAL PROCEDURE: REVISION OF LEFT L5 SCREW. LEVELS INVOLVED IN ADDITIONAL SURGICAL PROCEDURE: L5/S1 SPECIFY THE RELATEDNESS OF THE ADDITIONAL SURGICAL PROCEDURE TO SURGICAL CONSTRUCT AND/OR THE STUDY PROCEDURE: RELATED PLF GRAFTING M

  Patient problems: Pain

  MAUDE report 15415853 ↗
• InjuryJul 29, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. LEVELS IMPLANTED: L5-S1 PRE-OPERATIVE DIAGNOSIS: PAIN IN THE LEGS AND HARD GOING TO THE RESTROOM, MOVEMENT IN THE DISC SPACE IT WAS REPORTED THAT THE L5 SCREWS FELT SOLID BUT THE S1 SCREWS WERE A BIT LOOSE AND WERE THEREFORE CHANGED. PSEUDARTHROSIS WAS REPORTED IN THE PATIENT. SOME FUSION OCCURRED BUT NOT COMPLETELY. THE PATIENT COMPLAINED FROM PAIN AND A STANDING X-RAY WAS DONE WHERE MOVEMENT WAS NOTICED AND THE PATIENT PLANNED FOR REVISION DUE TO THAT. THE PATIENT WAS ON PAIN MEDICATION. TWO S1 SCREWS WERE REMOVED AND THE AREA AROUND THE DISC SPACE AND THE FACETS WAS DECORTICATED. THE PATIENT'S ISSUE HAS BEEN RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED REGARDING THE EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 15128053 ↗
• MalfunctionNov 29, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH NEURO STENOSIS AND UNDERWENT LUMBAR SPINE FUSION AT L5-S1. DURING THE SURGERY, THE IMPLANT BROKE WHEN SURGEON TRIED TO IMPLANT. BROKEN IMPLANTS WERE REMOVED AND REPLACED WITH ANOTHER IMPLANT. THE PRODUCTS CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT REMAINED IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8118004 ↗
• InjuryNov 27, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH PSEUDOARTHROSIS AND UNDERWENT SCREW REMOVAL AT S1, ANTERIOR LUMBAR INTERBODY FUSION (ALIF) POST FUSION AT T5-ILIUM. POST-OP, SCREW WAS FOUND TO BE BROKEN. THE PATIENT DID NOT ACHIEVE FUSION. REVISION SURGERY WAS PERFORMED FOR NON-FUSION. NO FRAGMENT REMAINS IN THE PATIENT. PATIENT COMPLICATIONS REPORTED TO BE UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 8108913 ↗
• MalfunctionNov 27, 2018Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HEAD OF MULTI-AXIAL SCREW DISLOCATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8104904 ↗
• InjuryJul 24, 2018Break; Component Missing

  IT WAS REPORTED THAT THE PATIENT UNDERWENT L5-S1 FUSION SURGERY IN (B)(6) 2017 FOR AN OLISTHESIS SYNDROME. POST-OP, SCREW BREAKAGE AND SOME CARTILAGE WAS REPORTED IN THE WOUND AROUND L5-S1. THE BROKEN, MISSING FRONT PART OF THE SCREW WAS LEFT IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant; Post Operative Wound Infection

  MAUDE report 7713214 ↗
• InjuryDec 1, 2017Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT L4-S1 FUSION. POST OP, THE PATIENT HAD PAIN AS THE SCREW WAS REPORTED BROKEN. AS A RESULT, A REVISION SURGERY WAS PERFORMED TO EXPLANT THE BROKEN SCREW. NO FRAGMENTS REMAINED IN THE PATIENT. THE PATIENT ACHIEVED SOLID FUSION. NO PATIENT COMPLICATIONS AFTER THE REVISION SURGERY WERE REPORTED.

  Patient problems: Pain

  MAUDE report 7073930 ↗

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.