INNOVERSE Spinal System NPA6545PRQRecalls & reported problems
CG MedTech Co.,Ltd. · Class 2 · Implant
Data updated Oct 18, 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 08800037596710), received between Sep 29, 2026 and Sep 29, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
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.
MalfunctionSep 29, 2026Detachment of Device or Device Component
During a surgical procedure, while adjusting the position of the Rod, separation of the Screw from the Tulip (Head) of a Pedicle Screw occurred. No patient harm resulted from this event. The separated screw was removed and replaced with another screw, and the surgery was completed without further incident.A review of the production and inspection records for the separated POLYAXIAL RED. SCREW (QUAD), 6.5 x 45mm (Lot No. 24A15008), confirmed that raw materials meeting the required chemical composition and mechanical property specifications were used, and that the product's dimensions and appearance were manufactured in conformance with the design specifications. No other anomalies were identified in the production or inspection records.In this Pedicle Screw design, the Inner Cap inside the Tulip engages the head of the Screw to prevent it from disengaging. During Rod adjustment, if the Inner Cap becomes pinched at the top of the Tulip, a gap can form that allows the Collet portion of the Inner Cap to open wider than normal. This can allow the Screw head to pass through the widened Collet, resulting in separation of the Screw from the Tulip. However, once the Rod and Set Screw are pr
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927670 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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