INNOVERSE Spinal System NPA8570PSQRecalls & reported problems
CG MedTech Co.,Ltd. · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08800247364765), received between Mar 5, 2026 and Mar 5, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Structural Problem” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Structural Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2026Structural Problem
INITIAL SURGERY WAS PERFORMED ON (B)(6) 2025. DURING FOLLOW-UP EVALUATION, AN X-RAY TAKEN AROUND (B)(6) 2026 IDENTIFIED A FRACTURE AT THE NECK REGION OF THE ILIAC SCREW IMPLANTED AT THE S2 LEVEL. A REVISION SURGERY WAS PERFORMED ON(B)(6) 2026 TO REMOVE THE FRACTURED SCREW, AND THE IMPLANT WAS REPLACED. THE FRACTURED DEVICE WAS RETRIEVED, AND THE MANUFACTURING AND INSPECTION RECORDS FOR THE ASSOCIATED LOT WERE REVIEWED. THE INVOLVED DEVICE WAS POLYAXIAL STD. SCREW (QUAD) -8.5X70 MM (LOT NO. 24K22130). REVIEW OF MANUFACTURING AND INSPECTION RECORDS CONFIRMED THAT COMPLIANT RAW MATERIAL WITHIN THE REQUIRED CHEMICAL COMPOSITION AND MECHANICAL PROPERTY SPECIFICATIONS WAS USED, AND THAT THE DEVICE GEOMETRY, DIMENSIONS, AND VISUAL APPEARANCE MET APPLICABLE SPECIFICATIONS. THE DEVICE WAS DESIGNED TO MEET ASTM F1717 REQUIREMENTS CONSIDERING CLINICALLY RELEVANT LOADING CONDITIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24516102 ↗
Other Thoracolumbosacral pedicle screw system devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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