CD HORIZON SOLERA Spinal SystemRecalls & reported problems across all models
Medtronic Sofamor Danek, Inc. · 34 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 121
- Deaths reported
- 0
- Injuries reported
- 64
- Recalls
- 0
We found 34 models of CD HORIZON SOLERA Spinal System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 121 adverse event reports in the FDA's MAUDE database, received between Jan 3, 2017 and Sep 24, 2026 — classified as 64 injuries, 57 malfunctions.
The most frequently reported specific device problem is “Break” (34 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CD HORIZON SOLERA Spinal System problems
Device problems
- Break34
- Device Dislodged or Dislocated17
- Material Deformation17
- Loosening of Implant Not Related to Bone-Ingrowth12
- Migration10
- Mechanics Altered9
- Material Fragmentation6
- Migration or Expulsion of Device6
Patient problems
- No Clinical Signs, Symptoms or Conditions63
- No Known Impact Or Consequence To Patient27
- Pain20
- Device Embedded In Tissue or Plaque5
- Post Operative Wound Infection4
- Unspecified Musculoskeletal problem3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Failure of Implant2
CD HORIZON SOLERA Spinal System models
34 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CD HORIZON® SOLERA® Spinal System 6534530Thoracolumbosacral pedicle screw system32 reports
- CD HORIZON® SOLERA® Spinal System 6540530Thoracolumbosacral pedicle screw system13 reports
- CD HORIZON® SOLERA® Spinal System 54850016540Orthosis, spondylolisthesis spinal fixation11 reports
- CD HORIZON® SOLERA® Spinal System 54850016545Orthosis, spondylolisthesis spinal fixation9 reports
- CD HORIZON® SOLERA® Spinal System 54850017545APPLIANCE, FIXATION, SPINAL INTERLAMINAL8 reports
- CD HORIZON® SOLERA® Spinal System 6530530APPLIANCE, FIXATION, SPINAL INTERLAMINAL8 reports
- CD HORIZON® SOLERA® Spinal System 54850017550ORTHOSIS, SPINAL PEDICLE FIXATION6 reports
- CD HORIZON® SOLERA® Spinal System 54850015545ORTHOSIS, SPINAL PEDICLE FIXATION3 reports
- CD HORIZON® SOLERA® Spinal System 54850017540Pedicle screw spinal system, adolescent idiopathic scoliosis3 reports
- CD HORIZON® SOLERA® Spinal System 641003050Orthopedic stereotaxic instrument2 reports
- CD HORIZON® SOLERA® Spinal System X0914079ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- CD HORIZON® SOLERA® Spinal System 651000040INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT2 reports
- CD HORIZON® SOLERA® Spinal System 5564320ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- CD HORIZON® SOLERA® Spinal System 641003080APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- CD HORIZON® SOLERA® Spinal System 54850016535Orthosis, spondylolisthesis spinal fixation1 report
- CD HORIZON® SOLERA® Spinal System 54850015530Orthosis, spondylolisthesis spinal fixation1 report
- CD HORIZON® SOLERA® Spinal System 54850016550DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)1 report
- CD HORIZON® SOLERA® Spinal System 54850017555Orthosis, spondylolisthesis spinal fixation1 report
- CD HORIZON® SOLERA® Spinal System 641100075Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- CD HORIZON® SOLERA® Spinal System 641100060APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- CD HORIZON® SOLERA® Spinal System 641100050APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- CD HORIZON® SOLERA® Spinal System 641100040Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- CD HORIZON® SOLERA® Spinal System 651003035Orthopedic stereotaxic instrument1 report
- CD HORIZON® SOLERA® Spinal System 651003045APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- CD HORIZON® SOLERA® Spinal System 651003070Thoracolumbosacral pedicle screw system1 report
- CD HORIZON® SOLERA® Spinal System 654000140Appliance, fixation, spinal intervertebral body1 report
- CD HORIZON® SOLERA® Spinal System 651000065Thoracolumbosacral pedicle screw system1 report
- CD HORIZON® SOLERA® Spinal System 654100045Appliance, fixation, spinal intervertebral body1 report
- CD HORIZON® SOLERA® Spinal System 654100075Orthopedic stereotaxic instrument1 report
- CD HORIZON® SOLERA® Spinal System 651100045APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- CD HORIZON® SOLERA® Spinal System 55720005550Appliance, fixation, spinal intervertebral body1 report
- CD HORIZON® SOLERA® Spinal System 55720005545ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- CD HORIZON® SOLERA® Spinal System 55720006550APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- CD HORIZON® SOLERA® Spinal System 55720008550APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
Recent CD HORIZON SOLERA Spinal System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Detachment of Device or Device Component
Information was received from multiple sources (Manufacturer Representative, Healthcare Provider, Distributor) regarding a Patient h aving Spinal therapy. It was reported that during lumbar vertebral implant procedure involving placement of a Solera Voyager screw, rod positioning, and locking cap tightening, the ridges detached from the locking cap. The physician replaced the affected locking cap with a different locking cap. No patient complications, injury, hospitalization, or medical or surgical intervention to prevent permanent impairment were reported as a result of this event. Additional information was received that reporting that after the pedicle screw and rod were placed, the physician attempted to tighten the locking screw (6540530) clockwise but noticed it was not tightening properly. Upon removing and inspecting the device, the physician observed that one of the ridges had detached from the locking mechanism and the other ones were severely damaged; consequently, a different device was used, which functioned properly. There was no issue with the rod, it was only with the locking screw.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880920 ↗InjurySep 22, 2026Use of Device Problem
Information was received from healthcare provider (HCP) via a manufacturer representative regarding a Patient having Open surgery Spinal therapy for degenerative spine condition. It was reported that during the procedure, difficult rod placement was encountered. The loaner set intended for the Voyager 4.75 mm system had been replenished with Voyager 5.5 mm implants, and wrong-diameter rods were placed. The surgeon was unable to lock the system with the locking nuts. The planned minimally invasive surgery was converted to open surgery, and the wound was opened on one side to remove the incorrect rods. The incorrect rods were explanted and replaced. Surgical time was extended by approximately 1 hour. There were unknown patient symptoms or complications reported. Additional information received from the manufacturer representative that there was no patient symptoms reported. Additional information received from the manufacturer representative that the levels involved was L5-S1. The quantity of the reported products were 2 minimal invasive rods 5.5.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50850147 ↗InjurySep 22, 2026Use of Device Problem
Information was received from healthcare provider (HCP) via a manufacturer representative regarding a Patient having Open surgery Sp inal therapy for degenerative spine condition. It was reported that during the procedure,difficult rod placement was encountered. The loaner set intended for the Voyager 4.75 mm system had been replenished with Voyager 5.5 mm implants, and wrong-diameter rods were placed. The surgeon was unable to lock the system with the locking nuts. The planned minimally invasive surgery was converted to open surgery, and the wound was opened on one side to remove the incorrect rods. The incorrect rods were explanted and replaced. Surgical time was extended by approximately 1 hour. There were unknown patient symptoms or complications reported. Additional information received from the manufacturer representative that there was no patient symptoms reported. Additional information received from the manufacturer representative that the levels involved was L5-S1. The quantity of the reported products were 2 minimal invasive rods 5.5.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50850145 ↗MalfunctionJul 17, 2026Material Deformation
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A SCREW USED ON PATIENT HAVING PERCUTANEOUS PEDICLE SCREW FIXATION OF THE LUMBAR SPINE FOR L2 VERTEBRAL BODY FRACTURE (TYPE B2), MULTIPLE TRAUMA DUE TO A TRAFFIC ACCIDENT. IT WAS REPORTED THAT, DURING SURGERY, THE MULTI AXIAL SCREW AND SET SCREW WERE USED IN ACCORDANCE WITH THE RECOMMENDED PROCEDURE, BUT THE INNER LOCKING SCREW COULD NOT BE PROPERLY ENGAGED AFTER THREE INSERTION ATTEMPTS. UPON REMOVAL, DAMAGED (STRIPPED) THREADS AT THE SCREW HEAD WERE IDENTIFIED. 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 25855291 ↗MalfunctionFeb 24, 2026Mechanics Altered
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT DIAGNOSED WITH SPINAL DEGENERATION AT L4¿5 AND UNDERWENT MIS-TLIF SURGERY. IT WAS REPORTED THAT WHEN ATTEMPTING TO SECURE THE ROD, THE NUT COULD NOT BE PROPERLY LOCKED DESPITE MULTIPLE ATTEMPTS. THE SURGEON THEN REPLACED THE SCREW WITH ANOTHER SCREW OF THE SAME SIZE, AFTER WHICH THE NUT WAS SUCCESSFULLY LOCKED AND THE SURGERY WAS COMPLETED SMOOTHLY. 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 24425671 ↗MalfunctionDec 30, 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 PRODUCT USED FOR SPINAL FUSION THERAPY IN A PATIENT WITH CLINICAL ID (B)(6), STUDY NAME AILLIANCE MDT22045CSTAIL. IT WAS REPORTED THAT AT THE 12-MONTH FOLLOW-UP VISIT, IT WAS NOTED THAT THE SUBJECT HAD NOT FULLY FUSED AT ALL TREATED LEVELS AND ALL THE IMPLANTED DEVICES DID NOT APPEAR STABLE AND SECURE. THERE WERE NO FURTHER PATIENT COMPLICATIONS OR SYMPTOMS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THERE IS NO ASSESSMENTS MADE BY SPONSOR, INVESTIGATOR AND CEC REGARDING THE RELATEDNESS FOR PRODUCT/THERAPY/PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT PATIENT IS DOING WELL OVERALL, AND CERTAINLY MUCH BETTER THAN PRE-OP, AND IS QUITE SATISFIED WITH HIS CURRENT STATE. THERE IS NO NEED TO GO THROUGH ANOTHER MAJOR SURGERY, DESPITE THE CT SHOWING PSEUDARTHROSIS (NONUNION) AT THE UPPERMOST FUSION LEVEL L1-2. AS THE L1 SCREWS ARE GROSSLY LOOSENED, THE LIKELIHOOD OF THAT SEGMENT GOING ON TO SOLID UNION IS VERY LOW. AS SUCH, SURGEON DO NOT THINK THAT BONE STIMULATOR IS LIKELY TO BE OF BENEFIT AND EXPLAINED THAT IT IS ESSENTIALLY RIGHT NOW FUNCTIONING
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23919816 ↗MalfunctionDec 26, 2025Product Quality Problem; Material Deformation; Product Quality Problem; Material Deformation
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN L4/5 SPINAL FUSION PROCEDURE IN A PATIENT. IT WAS REPORTED THAT THE CUSTOMER HAD THE MAS SCREW IMPLANTED AND WAS SUBSEQUENTLY UNABLE TO SECURE THE SET SCREWS TO THE ROD. THIS WAS DUE TO A DEFECT IN THE THREAD OF THE PEDICLE SCREW. 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 23894871 ↗InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING AN EVENT WHICH OCCURRED POST A CLINICAL STUDY (STUDY ID: (B)(4) L2-L5 INTERBODY FUSION PROCEDURE IN A PATIENT (PATIENT ID: (B)(6). PATIENT MEDICAL HISTORY: CHRONIC PAIN, LOWER URINARY TRACT INFECTIOUS DISEASE, OBESITY, PRIMARY OSTEOARTHRITIS OF LEFT HIP, SCOLIOSIS OF LUMBAR SPINE, UNSPECIFIED SCOLIOSIS TYPE. INTERVENTIONS: PATIENT WAS HOSPITALIZED FROM ON (B)(6) 2025 FOR WOUND IRRIGATION AND DEBRIDEMENT. IT WAS REPORTED THAT PATIENT HAD WOUND INFECTION AFTER SURGERY WITH SPECIFIC SYMPTOMS OF WOUND DISCHARGE AND VISIBLE DEHISCENCE CAUSING WOUND IRRIGATION AND DEBRIDEMENT PROCEDURE WITH HOSPITALIZATION. NO PRODUCT MALFUNCTION REPORTED. AS PER SITE RELATED ASSESSMENT, EVENT WAS POSSIBLY RELATED TO DEVICE AND CAUSALLY RELATED TO STUDY PROCEDURE. MRI WAS DONE WHICH SHOWED FLUID COLLECTION AND SURGICAL WOUND INFECTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Post Operative Wound Infection
MAUDE report 23816012 ↗InjuryDec 10, 2025Device Handling Problem; Device Handling Problem
INFORMATION WAS RECEIVED FROM MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE SPINAL THERAPY. IT WAS REPORTED THAT LEVELS IMPLANTED WAS L4/L5/S1. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. REP CONFIRMED THAT THE TIGHTENING NUT WAS NOT TORQUED TO FAILURE AS PER CORRECT PROCEDURE. PRE OP DIAGNOSIS OF THE EVENT WAS PAIN DUE TO MICROMOVEMENTS AS THE SYSTEM WAS NOT FIXED. CLAMPING NUT NOT TIGHTENED. THE PRODUCT EXPLANTED ON (B)(6) 2025.
Patient problems: Pain
MAUDE report 23775009 ↗MalfunctionNov 14, 2025Break; Fracture; Break; Fracture
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, DISTRIBUTOR) REGARDING A PATIENT HAVING VOYAGER + CRES CENT SURGERY CASE. IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE INVOLVING DECOMPRESSION AND L2-L3 DISC REPLACEMENT, FOUR VOYAGER SCREWS WERE FIXED INTO THE L2-L3 VERTEBRAL BODIES UNDER C-ARM FLUOROSCOPIC GUIDANCE. AFTER PLACEMENT OF TWO DISC CRESCENT, THE SURGICAL TEAM PROCEEDED TO INSERT SIX VOYAGER SCREWS, SIX SET SCREW, AND TWO RODS. HOWEVER, DURING THE ROD INSERTION MANEUVER, THE BREAK-OFF SECTION OF ONE VOYAGER SCREW FRACTURED. UPON INSPECTION, THE SCREW WAS DEEMED UNUSABLE AND HAD TO BE REPLACED WITH A NEW ONE. 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 23552633 ↗MalfunctionOct 27, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION SPINAL THERAPY AT L5-S1. IT WAS REPORTED THAT A BROKEN SCREW WAS DETECTED IN S1 ON THE RIGHT. THE BROKEN SCREW WAS IDENTIFIED WHILE THE IMPLANTS REMAINED IN PLACE, AND THE SPECIFIC BATCH OF THE BROKEN SCREW WAS NOT DETERMINED. THERE WERE UNKNOWN PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE ARE CURRENTLY NO PLANS TO PERFORM REVISION SURGERY TO REPLACE THE BROKEN SCREW IN S1 ON THE RIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23388571 ↗MalfunctionOct 27, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION SPINAL THERAPY AT L5-S1. IT WAS REPORTED THAT A BROKEN SCREW WAS DETECTED IN S1 ON THE RIGHT. THE BROKEN SCREW WAS IDENTIFIED WHILE THE IMPLANTS REMAINED IN PLACE, AND THE SPECIFIC BATCH OF THE BROKEN SCREW WAS NOT DETERMINED. THERE WERE UNKNOWN PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE ARE CURRENTLY NO PLANS TO PERFORM REVISION SURGERY TO REPLACE THE BROKEN SCREW IN S1 ON THE RIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23388569 ↗MalfunctionOct 27, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION SPINAL THERAPY AT L5-S1. IT WAS REPORTED THAT A BROKEN SCREW WAS DETECTED IN S1 ON THE RIGHT. THE BROKEN SCREW WAS IDENTIFIED WHILE THE IMPLANTS REMAINED IN PLACE, AND THE SPECIFIC BATCH OF THE BROKEN SCREW WAS NOT DETERMINED. THERE WERE UNKNOWN PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE ARE CURRENTLY NO PLANS TO PERFORM REVISION SURGERY TO REPLACE THE BROKEN SCREW IN S1 ON THE RIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23388566 ↗MalfunctionOct 27, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION SPINAL THERAPY AT L5-S1. IT WAS REPORTED THAT A BROKEN SCREW WAS DETECTED IN S1 ON THE RIGHT. THE BROKEN SCREW WAS IDENTIFIED WHILE THE IMPLANTS REMAINED IN PLACE, AND THE SPECIFIC BATCH OF THE BROKEN SCREW WAS NOT DETERMINED. THERE WERE UNKNOWN PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE ARE CURRENTLY NO PLANS TO PERFORM REVISION SURGERY TO REPLACE THE BROKEN SCREW IN S1 ON THE RIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23388565 ↗MalfunctionSep 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PATIENT ENROLLED IN THE "ALLIANCE" CLINICAL STUDY PRESENTED WITH LOOSENING OF UIV T4 SCREWS AND MULTILEVEL THORACIC PSEUDARTHROSIS. DESPITE A HISTORY OF SCOLIOSIS, PSEUDARTHROSIS AFTER SPINAL FUSIONS, FLATBACK SYNDROME, AND CHRONIC SACROILIAC JOINT PAIN, THE PATIENT REMAINED ASYMPTOMATIC, WITH NO SURGICAL INTERVENTION REQUIRED. NO ASSESSMENT FOR PRODUCT/THERAPY/PROCEDURE RELATEDNESS MADE BY THE INVESTIGATOR AND SPONSOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23082478 ↗
Other Medtronic Sofamor Danek, Inc. products
- CD HORIZON Spinal System342 models · 2,323 reports
- GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM)25 models · 12 reports · 14 recalls
- METRx System5 models · 672 reports
- INFUSE Bone Graft6 models · 576 reports · 1 recall
- CD HORIZON SOLERA VOYAGER Spinal System60 models · 411 reports
- POWEREASE Instruments8 models · 331 reports · 1 recall
- Catalyft PL Expandable Interbody System16 models · 279 reports · 1 recall
- INFINITY Occipitocervical Upper Thoracic System35 models · 63 reports · 5 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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