CD HORIZON® Spinal System 55840006545Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00613994971753), received between Sep 6, 2017 and Jun 3, 2026 — classified as 15 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2026Break

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL DECOM PRESSION AND FUSION REVISION AND T2-L3 LEVELS WERE IMPLANTED AND BROKEN SCREW WAS THE PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE. IT WAS REPORTED THAT THE BROKEN SCREW HEAD WAS REMOVED FROM THE ROD AND THE SHAFT WAS LEFT IN THE BONE. THE BROKEN SCREW WAS THROUGH THE RIGHT PEDICLE OF T12 .THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED AS THERE'S NO ALLEGATION OF THE ROD OR SHAFT AND NO ADDITIONAL/REVISION SURGERY PLANNED TO REMOVE SCREW SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25371074 ↗
• 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 (B)(6) 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.. (B)(6) 2025, UPDATE RECEIVED SITE RELATED ASSESSMENT: PROBABLY RELATED TO STUDY DEVICE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 23991774 ↗
• InjuryDec 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING A POSTERIOR SPINAL FUSION PROCEDURE, THE T20 TORX DRIVER WAS STRIPPED. THE TIP OF THE DRIVER WAS FRACTURED AND CROSSLINK FRACTURED WHERE IT ATTACHES TO ROD. THE FRACTURED IMPLANTS OCCURRED PRIOR TO THE REVISION SURGERY ON 11/13. IT WAS SUSPECTED BY THE PHYSICIAN THAT THE IMPLANTS (SCREW AND CROSSLINK) FRACTURED DUE TO STRESS ON HARDWARE FROM NON-FUSION OF THE PATIENT. THE CROSSLINK AND SCREW WERE EXPLANTED FROM THE PATIENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23701741 ↗
• InjuryOct 20, 2025Break; Loosening of Implant Not Related to Bone-Ingrowth; Break; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING FUSION SPINAL THERAPY. IT WAS REPORTED THAT THE TULIP FROM THE MAS-SCREW HAD COME LOOSE FROM THE SCREW AND THE RODS IN THE CONSTRUCTION WERE BROKEN. THE BROKEN TULIP WAS ON LEFT L4 AND THE ROD ON THE LEFT SIDE WAS BROKEN ON TWO SPOTS WHILE THE ROD ON THE RIGHT SIDE WAS BROKEN IN ONE POSITION. THERE WAS PAIN IN THE AREA OF THE BACK WHERE THE BROKEN SCREW WAS LOCATED NEAR L4. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 23337367 ↗
• 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 22103624 ↗
• InjuryMay 28, 2025Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST AN OPEN THORACIC SPINAL FIXATION AT T6-8 FOR A T7 TUMOR STABILIZATION IN A PATIENT DIAGNOSED WITH RENAL CANCER WITH SECONDARY METASTASIS TO THE SPINE T6-8 TUMOR. IT WAS REPORTED THAT SCREW WAS PLACED BY ANOTHER SURGEON 4 YEARS AGO (EXACT DATE UNKNOWN). A REVISION/EXTENSION FUSION PROCEDURE WAS BEING PERFORMED DUE TO THE PATIENT'S PATHOLOGY PROGRESSING- TUMOR WHICH HAD SPREAD TO THE PREVIOUSLY INSTRUMENTED LEVELS AFFECTING THE BONE QUALITY AND PREVIOUS SCREWS HOLD. SCREW WAS DISCOVERED FRACTURED IN-SITU (A THIRD OF THE WAY DOWN THE THREAD) WHEN REVISING AND DISCARDED. TULIP AND PROXIMAL THIRD OF THE SCREW WAS REMOVED. TWO THIRDS OF THE DISTAL SCREW REMAIN IN-BONE AT T8 LEVEL. SURGEON DIDN'T DEEM REMOVAL OF THE REST OF THE SCREW NECESSARY DUE TO PATHOLOGY AND CONDITION OF THE PATIENT. THE SURGEON REVISING THE FUSION BELIEVED THE PRODUCT FAILED DUE TO THE PATIENTS CONDITION. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22094128 ↗
• MalfunctionApr 22, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR L2 FRACTURE. IT WAS REPORTED THAT, PATIENT LOST MOTOR FUNCTIONS UPON TORQUING OFF THE SCREWS. AS A RESULT, THE SCREWS WERE PULLED OUT. SURGEON BELIEVES THE COCR STRENGTH AND TIGHTNESS ASPECT OF THE ROD CONTRIBUTED TO THE LOCKING OF THE SCREW HEADS. DURING THE FINAL TORQUING OF THE SCREWS THAT IT FELT ABNORMALLY TIGHT. SURGEON BELIEVES THE ROD WAS THE CAUSE OF THE ISSUE DUE TO THE TIGHTNESS AFTER TORQUING OFF. THE PROCEDURE WAS SUCCESSFUL. AFTER THE LOSS OF MOTOR FUNCTION, SURGEON REMOVED THE SET SCREWS, RODS, AND A COUPLE SCREWS AND THEN FURTHER DECOMPRESSED THE SPINE. PROCEDURE OR TECHNIQUE PERFORMED WAS POSTERIOR THORACOLUMBAR SPINAL FUSION. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 21879938 ↗
• MalfunctionMar 10, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR L2 FRACTURE. IT WAS REPORTED THAT, PATIENT LOST MOTOR FUNCTIONS UPON TORQUING OFF THE SCREWS. AS A RESULT, THE SCREWS WERE PULLED OUT. SURGEON BELIEVES THE COCR STRENGTH AND TIGHTNESS ASPECT OF THE ROD CONTRIBUTED TO THE LOCKING OF THE SCREW HEADS. DURING THE FINAL TORQUING OF THE SCREWS THAT IT FELT ABNORMALLY TIGHT. SURGEON BELIEVES THE ROD WAS THE CAUSE OF THE ISSUE DUE TO THE TIGHTNESS AFTER TORQUING OFF. THE PROCEDURE WAS SUCCESSFUL. AFTER THE LOSS OF MOTOR FUNCTION, SURGEON REMOVED THE SET SCREWS, RODS, AND A COUPLE SCREWS AND THEN FURTHER DECOMPRESSED THE SPINE. PROCEDURE OR TECHNIQUE PERFORMED WAS POSTERIOR THORACOLUMBAR SPINAL FUSION. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 21556633 ↗
• InjuryAug 13, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING WHO HAD STANDARD OPEN TECHNIQUE FOR INSERTION OF PEDICLE SCREWS AT L4 AND L5 DUE TO L4/L5 CENTRAL CANAL STENOSIS. IT WAS REPORTED THAT SCREWS BROKE AFTER IMPLANTATION. THE SCREW WAS INSERTED AT L5 AND BROKE APPROXIMATELY 10MM DOWN FROM THE HEAD. THE PATIENT EXPERIENCED VIBRATION SENSATIONS IN THE LOWER BACK AT THE IMPLANT SITE.  PATIENT WAS BROUGHT BACK TO OT FOR A REMOVAL/REVISION OF BROKEN L5 SCREWS AND EXTENSION OF PREVIOUS L4/5 FUSION TO S1. A PARTIAL EXPLANT WAS PERFORMED ON THE L5 PEDICLE SCREWS. PART OF THE SCREW SHAFT REMAINED IN THE L5 PEDICLE AS IT WAS DEEMED TOO RISKY TO REMOVE THE BROKEN PORTION THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19971058 ↗
• InjuryAug 13, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING WHO HAD STANDARD OPEN TECHNIQUE FOR INSERTION OF PEDICLE SCREWS AT L4 AND L5 DUE TO L4/L5 CENTRAL CANAL STENOSIS. IT WAS REPORTED THAT SCREWS BROKE AFTER IMPLANTATION. THE SCREW WAS INSERTED AT L5 AND BROKE APPROXIMATELY 10MM DOWN FROM THE HEAD. THE PATIENT EXPERIENCED VIBRATION SENSATIONS IN THE LOWER BACK AT THE IMPLANT SITE. PATIENT WAS BROUGHT BACK TO OT FOR A REMOVAL/REVISION OF BROKEN L5 SCREWS AND EXTENSION OF PREVIOUS L4/5 FUSION TO S1. A PARTIAL EXPLANT WAS PERFORMED ON THE L5 PEDICLE SCREWS. PART OF THE SCREW SHAFT REMAINED IN THE L5 PEDICLE AS IT WAS DEEMED TOO RISKY TO REMOVE THE BROKEN PORTION THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19971047 ↗
• InjuryJun 18, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH A SCREW IN AN UNKNOWN SPINAL THERAPY FOR A DEFORMITY CORRECTION. IT WAS REPORTED THAT THERE WAS LOOSENING OF THE SETSCREW DUE TO WHICH IT WAS EXPLANTED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19556177 ↗
• InjuryMay 6, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A O PEN PLF PROCEDURE. IT WAS REPORTED THAT SCREW WAS IMPLANTED BUT BROKE ON (B)(6) 2020. PATIENT UNDERWENT A REVISION SURGERY. 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 19247034 ↗
• InjuryApr 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT NO FALL OR OTHER TRAUMATIC EVENT OCCURRED. AT SOME POINT AFTER SURGERY THE PATIENT¿S SPINE ABOVE THE LEVELS OF FUSION ¿FELL FORWARD¿, IE ¿SHIFTED FORWARD¿ IE WENT FROM A STATE OF MORE LORDOSIS TO LESS LORDOSIS. THE INCREASED STRAIN ON THE FUSION CONSTRUCT PULLED OUT THE SCREWS AT L2. NO FAILURE OR BREAKAGE OF ANY HARDWARE IN THE CONSTRUCT. PATIENT HAD NO SYMPTOMS INDICATION THE L2 SCREWS PULLED OUT AND NOTICED ON POST-OP X-RAY FOLLOW-UP. IN SECOND SURGERY THE SURGEON REPLACED THE SCREWS AT L2 AND EXTENDED THE CONSTRUCT TO L1. NO ADVERSE PATIENT OUTCOME AFTER EITHER SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19048351 ↗
• InjuryJun 29, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD SCREW EXPLANT. IT WAS REPORTED THAT S1 SCREW WAS BROKEN. SCREW WAS EXPLANTED. 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 17224131 ↗
• 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 16551217 ↗
• InjuryJul 22, 2020Break; Break

  SURGICAL HISTORY: INFUSE WAS USED IN THE PRIMARY OPERATION IN 2019. PRE-OP DIAGNOSIS: SPINAL STENOSIS PROCEDURE: NAVIGATED POSTERIOR SPINAL FUSION LEVELS IMPLANTED: S1 IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE SCREW WAS BROKEN. HENCE, THE REVISION SURGERY WAS PERFORMED FOR REPLACEMENT OF SCREW AND EXTENDING THE FUSION UP TO T9 FOR ACUTE SPINAL STENOSIS. PATIENT HAD A PRIMARY SPINAL FUSION FROM L3-S1 IN 2019. ONE CAGE IMPLANTED AT L3/4. PARTIAL SHAFT OF SCREW STILL INSIDE THE PATIENT. ANY COMPLICATION TO THE PATIENT WAS UNKNOWN. THE COMPLICATION IS THAT THE PATIENT NEEDED TO HAVE ANOTHER OPERATION IN A VERY SHORT TIME WITHIN ONE YEAR OF THE PRIMARY SURGERY. SHE WAS COMPLAINING OF PAIN DOWN HER RIGHT LEG WHICH IS THE SIDE WHERE THE SCREW BROKE.

  Patient problems: No Known Impact Or Consequence To Patient; Pain

  MAUDE report 10307688 ↗
• MalfunctionMar 28, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DEFORMITY; AND UNDERWENT A REVISION OF SPINE SURGERY AT L3-S1. INTRA-OP, WHILE TRYING TO IMPLANT THE ALLEGED SCREW AT SACRUM, IT WAS FOUND THAT THE SCREW WAS UNABLE TO TURN FURTHER. THE SURGEON WASN'T ABLE TO GO THROUGH THE SECOND CORTEX. THE SCREW WAS TAKEN OUT; AND IT WAS FOUND THAT THE THREAD, AT THE DISTAL PART OF THE SCREW, CAME LOOSE. THE ALLEGED SCREW WAS COMPLETELY EXPLANTED. IT APPEARED THAT WHILE THE SCREW WAS IN THE SACRUM, IT MIGHT HAVE TOUCHED ANOTHER SCREW (SOME PART) WHICH WAS STILL THERE. THIS MIGHT BE A REASON FOR THE SCREW THREAD TO HAVE LOOSENED; BUT THE SURGEON WAS NOT SURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9894771 ↗
• 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 9794975 ↗
• MalfunctionDec 26, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SPONDYLOLISTHESIS WITH SPINAL STENOSIS AT L4/L5 AND UNDERWENT SCREW INSERTION SURGERY. DURING SURGERY, AFTER INSERTING THE SCREW INTO THE VERTEBRAL BODY, THE SCREW HEAD SPLAYED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8195292 ↗
• InjurySep 6, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT FUSION SURGERY AT L4-S1. REPORTEDLY, POST-OP, THE PATIENT HAD A SUPERFICIAL WOUND INFECTION THAT HEALED WELL AFTER ANTIBIOTIC TREATMENT. SINCE (B)(6) 2017, THE PATIENT HAD GAINED PAIN IN THE BACK AND NOTED A SPARKLING NOISE IN HER BACK. A CT WAS CONDUCTED IN (B)(6) 2017, WHICH SHOWED THAT THE SCREWS WERE FINE. A SUPPLEMENTARY PROVOCATION CT IN (B)(6) 2017, HOWEVER, SHOWED BROKEN SCREW. THE PATIENT UNDERWENT REVISION SURGERY FOR REMOVAL OF BROKEN SCREW AND REST OF THE CONSTRUCT AS WELL. EVERYTHING WAS REPLACED WITH NEW IMPLANTS IN THE SURGERY. THE PATIENT HAD NOT ACHIEVED SOLID FUSION. THE TIPS FROM THE TWO BROKEN S1-SCREWS COULDN'T BE REMOVED AND WERE LEFT IN THE BODY AS THE SURGEONS DIDN'T WANT TO CAUSE MORE TISSUE TRAUMA AND RISK INFECTION.

  Patient problems: Device Embedded In Tissue or Plaque; Pain

  MAUDE report 6844240 ↗
• InjurySep 6, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT FUSION SURGERY AT L4-S1. REPORTEDLY, POST-OP, THE PATIENT HAD A SUPERFICIAL WOUND INFECTION THAT HEALED WELL AFTER ANTIBIOTIC TREATMENT. SINCE (B)(6) 2017, THE PATIENT HAD GAINED PAIN IN THE BACK AND NOTED A SPARKLING NOISE IN HER BACK. A CT WAS CONDUCTED IN (B)(6) 2017, WHICH SHOWED THAT THE SCREWS WERE FINE. A SUPPLEMENTARY PROVOCATION CT IN (B)(6) 2017, HOWEVER, SHOWED BROKEN SCREW. THE PATIENT UNDERWENT REVISION SURGERY FOR REMOVAL OF BROKEN SCREW AND REST OF THE CONSTRUCT AS WELL. EVERYTHING WAS REPLACED WITH NEW IMPLANTS IN THE SURGERY. THE PATIENT HAD NOT ACHIEVED SOLID FUSION. THE TIPS FROM THE TWO BROKEN S1-SCREWS COULDN'T BE REMOVED AND WERE LEFT IN THE BODY AS THE SURGEONS DIDN'T WANT TO CAUSE MORE TISSUE TRAUMA AND RISK INFECTION.

  Patient problems: Device Embedded In Tissue or Plaque; Pain

  MAUDE report 6844238 ↗

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.