CD HORIZON® Spinal System 5440030Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00613994790705), received between Jan 6, 2017 and Apr 28, 2026 — classified as 8 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (13 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Manufacturing, Packaging or Shipping Problem; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING TRANSVERSE LUMBAR INTERBODY FUSION PROCEDURE AT THE L4-5 SPINAL LEVELS WITH THE PRE-OPERATIVE DIAGNOSIS OF LUMBAR SPONDYLOLISTHESIS. IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON FOLLOWED THE CORRECT PROTOCOL YET THE TWO SET SCREWS WERE FOUND TO HAVE STRIPPED THREADS. 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 25017859 ↗
• MalfunctionApr 28, 2026Product Quality Problem; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING TRANSVERSE LUMBAR INTERBODY FUSION PROCEDURE AT THE L4-5 SPINAL LEVELS WITH THE PRE-OPERATIVE DIAGNOSIS OF LUMBAR SPONDYLOLISTHESIS. IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON FOLLOWED THE CORRECT PROTOCOL YET THE TWO SET SCREWS WERE FOUND TO HAVE STRIPPED THREADS. 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 25017805 ↗
• MalfunctionMar 26, 2026Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE SETSCREWS WERE STRIPPED. THE INTERNAL LOCKING SCREW WAS SUBSEQUENTLY FOUND TO HAVE STRIPPED THREADS. PROCEDURE PERFORMED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION. LEVELS TREATED WERE L4-L5. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699432 ↗
• MalfunctionMar 26, 2026Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE SETSCREWS WERE STRIPPED. THE INTERNAL LOCKING SCREW WAS SUBSEQUENTLY FOUND TO HAVE STRIPPED THREADS. PROCEDURE PERFORMED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION. LEVELS TREATED WERE L4-L5. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699069 ↗
• MalfunctionMar 25, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT WEAR ON SCREW THREAD WITH PRESENCE OF FILINGS, IMPOSSIBLE TO FIT. NO PATIENT INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT THIS EVENT HAPPENED IMMEDIATE AFTER OPENING THE PACKAGE (I.E OUT OF BOX FAILURE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21689709 ↗
• MalfunctionMar 13, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT TO BE IMPLANTED WITH A SCREW IN AN UNKNOWN SPINAL THERAPY FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT THAT THE SET SCREW WAS DAMAGED. THE DEVICE WAS NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVED IN THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT WAS NOT INJURED. AN ATTEMPT WAS MADE TO IMPLANT THE SCREW INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21591843 ↗
• MalfunctionFeb 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A PATIENT VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH SCREWS IN A FUSION. IT WAS REPORTED THAT THE PATIENT HAS PREVIOUSLY HAD SPINAL FUSION AT L2¿S1 ON (B)(6) 2018. THEY REMOVED THE ORIGINAL HARDWARE ON (B)(6) 2021, BUT THE FUSION HAD TAKEN HOLD AND THERE WERE LOOSE SCREWS AT S1. A NEW CONSTRUCT WAS PLACED AT L2¿L3 WITH INTERBODY CAGE WHICH FAILED VERY QUICKLY. THIS WAS REMOVED ON (B)(6) 2022 AS THE CAGE HAD MOVED 9MM AND THE SCREWS HAD LOOSENED SO MUCH THAT THEY COULD BE PULLED OUT OF THE BONE. A NEW CONSTRUCT WAS PLACED AT L2¿L5 AND MONTHLY MONITORING TOOK PLACE TO SEE IF FUSION WAS TAKING HOLD, BUT THE SCREWS WERE LOOSENING AGAIN. CT SCAN ON (B)(6) 2022 SHOWS THAT THE SCREWS WERE LOOSENING WITH A BROKEN SCREW AT L4. THE PATIENT HAD DEEP PAIN IN THE LOWER BACK, AN ITCHY BACK, AND DISCOMFORT. EVER SINCE THE SURGERIES, THE PATIENT'S FACE GETS RED WHEN SHAVING HIS FACE. THE PATIENT IS WEAKENED, IS HAVING ISSUES WITH INCONTINENCE, AND SWELLING IN AFFECTED AREAS. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: Discomfort; Hypersensitivity/Allergic reaction; Incontinence; Itching Sensation; Muscle Weakness/Atrophy; Pain; Swelling/ Edema

  MAUDE report 21353908 ↗
• MalfunctionFeb 6, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A REGULATORY BODY VIA MANUFACTURER REPRESENTATIVE REGARDING TWO SET SCREWS USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SCREWS WERE BROKEN, VISIBLE ON XRAY, PRIOR TO INCISION AND REMOVED BROKEN SCREW HEADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21321141 ↗
• InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THROUGH FOLLOW UP INFORMATION THAT IT IS ACUTE COMPRESSION FRACTURE - L1.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bone Fracture(s); Pain

  MAUDE report 21091309 ↗
• MalfunctionAug 22, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM A PATIENT VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH SCREWS IN A FUSION. IT WAS REPORTED THAT THE PATIENT HAS PREVIOUSLY HAD SPINAL FUSION AT L2¿S1 ON (B)(6)2018. THEY REMOVED THE ORIGINAL HARDWARE ON (B)(6)2021, BUT THE FUSION HAD TAKEN HOLD AND THERE WERE LOOSE SCREWS AT S1. A NEW CONSTRUCT WAS PLACED AT L2¿L3 WITH INTERBODY CAGE WHICH FAILED VERY QUICKLY. THIS WAS REMOVED ON (B)(6)2022 AS THE CAGE HAD MOVED 9MM AND THE SCREWS HAD LOOSENED SO MUCH THAT THEY COULD BE PULLED OUT OF THE BONE. A NEW CONSTRUCT WAS PLACED AT L2¿L5 AND MONTHLY MONITORING TOOK PLACE TO SEE IF FUSION WAS TAKING HOLD, BUT THE SCREWS WERE LOOSENING AGAIN. CT SCAN ON (B)(6)2022 SHOWS THAT THE SCREWS WERE LOOSENING WITH A BROKEN SCREW AT L4. THE PATIENT HAD DEEP PAIN IN THE LOWER BACK, AN ITCHY BACK, AND DISCOMFORT. EVER SINCE THE SURGERIES, THE PATIENT'S FACE GETS RED WHEN SHAVING HIS FACE. THE PATIENT IS WEAKENED, IS HAVING ISSUES WITH INCONTINENCE, AND SWELLING IN AFFECTED AREAS. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: Discomfort; Hypersensitivity/Allergic reaction; Incontinence; Itching Sensation; Muscle Weakness/Atrophy; Pain; Swelling/ Edema

  MAUDE report 15264058 ↗
• MalfunctionJun 15, 2022Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING EXTENSION OF SC OLIOSIS GROWTH RODS/SCOLIOSIS WITH SOLERA 4.75 SYSTEM DUE TO SCOLIOSIS. IT WAS REPORTED THAT THE SETSCREWS WAS EXTREMELY HARD TO REMOVE, HENCE THE BREAKING OF THE DRIVERS.  THERE WAS NO PATIENT SYMPTOM REPORTED. THE SURGERY WAS DELAYED TO GET EXTRA DRIVERS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14692655 ↗
• InjuryMay 31, 2022Defective Device; Loosening of Implant Not Related to Bone-Ingrowth; Defective Device; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (PATIENT, MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING AN EVENT WHICH OCCURRED POST A L4-S1 TLIF PROCEDURE IN A PATIENT DIAGNOSED WITH L4-S1 LUMBAR DEGENERATION. IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN ON RIGHT SIDE. AS PER THE RADIOGRAPHIC IMAGES, HCP ALLEGED THAT THE ROD AT L4 CAME OUT OF THE PEDICLE SCREW BUT THE SET SCREW WAS STILL COUNTER SUNK INTO TULIP OF PEDICLE SCREW. HCP ALLEGED THAT THE SET SCREW COULD HAVE HAD A DEFECT. PATIENT DID NOT ACHIEVE SOLID FUSION SINCE THE HARDWARE WAS LOOSE. REVISION SURGERY WAS PERFORMED ON (B)(6) 2022. THERE WERE NO CONCERNS OF FAULTY HARDWARE AT THE TIME IMAGES WERE TAKEN ON (B)(6) 2021. UPON REMOVAL OF THE SET SCREW ON (B)(6) 2022, THE HCP ALLEGED THAT THE SCREW COULD HAVE A DEFECT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 14545882 ↗
• MalfunctionNov 23, 2021Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY DUE TO L4-5 ARTHRODESIS. IT WAS REPORTED THAT SET SCREW WAS UNABLE TO SCREW TO THE HEAD OF THE SOLERA SCREW HEAD. A NEW SET SCREW WAS OPENED AND ATTACHED PERFECTLY. THERE WAS NO SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12866717 ↗
• MalfunctionMar 23, 2021Degraded; Mechanics Altered; Degraded; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF LUMBAR SPONDYLOLIS THESIS INVOLVED IN TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE. LEVELS TREATED: L4-5. IT WAS REPORTED THAT DURING PROCEDURE, THE SET SCREWS WOULD NOT ENGAGE IN THE HEAD OF THE SCREW. THEY TRIED SEVERAL DIFFERENT SET SCREWS, TRIED DIFFERENT REDUCING OPTIONS AND STILL COULDN'T GET THE SET SCREWS TO ENGAGE. THE PRODUCT CAME IN CONTACT WITH PATIENT. THERE WAS NO SLIPPING OF THE SET SCREW AND SET SCREWS WERE NOT STRIPPED. BUT, FOUND WEAR ON THE EDGES. NEW SET SCREWS FROM THE SET SCREW CADDY WERE USED IN THE PROCEDURE AND ALL 4 SET SCREWS WENT IN WITH NO PROBLEM. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. PATIENT IS ALIVE AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11553352 ↗
• MalfunctionFeb 24, 2021Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH HERNIATED DISC INVOLVED IN POS TERIOR LUMBAR DECOMPRESSION AND FUSION PROCEDURE. IT WAS REPORTED THAT AT INTRA-OP, THE SCREW THREAD WAS DEFORMED AND COULDN'T BE SCREWED INTO THE BODY. PRODUCT CAME IN CONTACT WITH PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. EVENT WAS ASSOCIATED WITH PATIENT. PRODUCT WAS UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. PRODUCT DID NOT BREAK. PATIENT IS ALIVE AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11371655 ↗
• MalfunctionFeb 10, 2021Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF HEMIVERTEBRAE IN NEED OF SEMI-VERTEBRAL SURGERY, POSTERIOR FIXATION USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE SCREW PLUG SLIPPED WHEN TIGHTENING SCREWS DURING SURGERY. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WAS A DELAY OF LESS THAN 60 MINS REPORTED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11306234 ↗
• MalfunctionFeb 8, 2021Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A TLIF (POSTERIOR LUMBAR SURGERY) IN A PATIENT DIAGNOSED WITH LUMBAR 4/5 SPINAL STENOSIS. IT WAS REPORTED THAT THE SCREW PLUGS WERE DAMAGED. WHEN SCREWING IN THE SCREW PLUG TO PRESS THE ROD, THE THREAD WAS DEFORMED. THE DATE OF IMPLANT AND EXPLANT IS (B)(6) 2021. PRODUCT WILL BE RETURNED, AND IT WAS REPLACED WITH A MEDTRONIC PRODUCT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11299222 ↗
• MalfunctionFeb 8, 2021Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A TLIF (POSTERIOR LUMBAR SURGERY) IN A PATIENT DIAGNOSED WITH LUMBAR 4/5 SPINAL STENOSIS. IT WAS REPORTED THAT THE SCREW PLUGS WERE DAMAGED. WHEN SCREWING IN THE SCREW PLUG TO PRESS THE ROD, THE THREAD WAS DEFORMED. THE DATE OF IMPLANT AND EXPLANT IS (B)(6) 2021. PRODUCT WILL BE RETURNED, AND IT WAS REPLACED WITH A MEDTRONIC PRODUCT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11299220 ↗
• MalfunctionDec 16, 2020Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH LUMBAR SPINAL STENOSIS FOR LUMBAR DISCECTOMY. IT WAS REPORTED THAT THE SCREW PLUG WAS SLIPPERY, AND THE SCREW COULD NOT BE FINALLY TIGHTENED. PRODUCT EXPLANTED AND WILL BE RETURNED. THERE WAS PATIENT INVOLVED IN THE EVENT. BUT THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11017578 ↗
• MalfunctionNov 5, 2020Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH LUMBAR DEGENERATION FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SCREW PLUG SLIPPED DURING OPERATION. PRODUCT EXPLANTED COMPLETELY AND WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10790323 ↗
• MalfunctionNov 4, 2020Difficult to Insert; Defective Device; Difficult to Insert; Defective Device

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT SPINAL THERAPY FOR RIGHT L5/S1 RADICULOPATHY. IT WAS REPORTED THAT WHEN NEW SOLERA SET SCREW WAS READY TO BE IMPLANTED AND ATTEMPTING TO INSERT SET SCREW, THE SURGEON NOTICED ISSUES WITH HIS ATTEMPT WITH DIFFICULTY TRYING TO INITIATE THREADING. THE SURGEON BROUGHT THE SET SCREW INTO HIS DIRECT VIEW TO INSPECT AND IT WAS FOUND TO HAVE A DEVIATED THREADING, BELIEVED TO BE A MANUFACTURING ISSUE. THE START OF THE THREADING WAS NOT CONTINUOUS, AND THE INTERFERENCE PREVENTED IT FROM BEING INSERTED. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2020: THE PRODUCT CAME IN CONTACT WITH THE PATIENT. ISSUE WITH PRODUCT WAS NOT IDENTIFIED UNTIL ATTEMPTING TO USE INTRA-OP. THE PROCEDURE WAS COMPLETED AS ROUTINE, USING OTHER MDT PRODUCTS. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2020: THE ITEM DESCRIBED IN THE INCIDENT IS NOT S STERILE PACKAGED ITEM. IT WAS A RESUPPLY OF CONSIGNMENT STOCK TO THE HOSPITAL, AND IS STERILIZED ON A TRAY IN THE HOSPITAL CSSD DEPARTMENT BEFORE IT IS IMPLANTED IN SURGERY. IT

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10783852 ↗
• MalfunctionAug 27, 2020Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT THAT OCCURRED DURING A POSTERIOR LUMBAR DECOMPRESSION AND FUSION SURGERY ON A PATIENT DIAGNOSED WITH LUMBAR DISC HERNIATION. IT WAS REPORTED THAT SCREW PLUG SLIPPED, AND A NEW SCREW PLUG WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE. PRODUCT WILL BE RETURNED AND WAS REPLACED WITH A MEDTRONIC PRODUCT. NO PATIENT INJURY / COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10458324 ↗
• InjuryAug 24, 2020Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF ANTERIOR LUMBAR 4,5 VERTEBRAL TUBERCULOSIS LESIONS. IT WAS REPORTED THAT INTRA-OP,SCREW PLUG SLIPPED. THE THREAD OF THE SCREW PLUG WAS EASY TO WEAR, AND THE SCREW PLUG COULD NOT BE LOCKED TIGHTLY. DEVICE IS EXPLANTED AND IT WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10441524 ↗
• MalfunctionJun 5, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH L4-S1 SPINAL STENOSIS; AND UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION DECOMPRESSION TECHNIQUE FOR POSTERIOR LUMBAR SPINE. INTRA-OP, THE SET SCREW ROD WAS DAMAGED; AND HENCE, THE SET SCREW WAS COMPLETELY EXPLANTED. THERE WERE NO PATENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10124911 ↗
• InjuryMay 23, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. IT WAS REPORTED THAT ANTEROPOSTERIOR AND LATERAL X-RAY TAKING LUMBAR FUSION PROVIDED. AN INTERESTING CONSTRUCT WITH AN OBLIQUE ARCUTATION OF THE BILATERAL RODS ARE PRESENT. THERE AT LEAST ONE PARTIAL SCREW SHRINK CONTAINED IN THE SUPERVALU VERTEBRAL BODY CONSISTENT WITH THE PROVIDED HISTORY OF FRACTURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10084489 ↗