Neo Medical Pedicle screw kit RD-00-90-PBRecalls & reported problems
Neo Medical SA · Rod kit pre-bent 90 mm (2x) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640177820235), received between Jun 20, 2025 and Jun 20, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Migration or Expulsion of Device1
Patient problems
- Arrhythmia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 20, 2025Migration or Expulsion of Device; Migration or Expulsion of Device
EVENT DESCRIPTION: THE SURGEON (CHU DIJON) REPORTED: "THE CASE WAS SIMPLE, HE DID IT WITH A SURGICAL RESIDENT, THERE WAS NO ALERT OR SPECIAL EVENT, EVERY-THING WENT FINE. THE REDUCTION STEPS WERE RESPECTED: -TIGHTENING WITH THE TORQUE LIMITER ALL SET-SCREWS UNTIL EVERYTHING IS AT THE LOWEST POSITION - THEN THE LAST MM IS TIGHTENED WITHOUT THE TORQUE LIMITER - CONTROL X-RAY IS MADE BEFORE BREAKING AND FOR CONTROLLING THE REDUCTION - FINAL TIGHTENING WITH STANDARD BREAKAGE OF THE 10N. M TORQUE LIMITER OF THE SET SCREW - NO CONTROL OF THE STABILITY OF ANY SET-SCREW WAS DONE AT THE END." THE IMMEDIATE POST-OP XRAY HAS BEEN PROVIDED (ROD IS IN THE CONSTRUCT, CHU DIJON), AND AN X-RAY AFTER THE PROBLEM OCCURRED HAS BEEN PROVIDED (ROD DETACHED AND MOVED TO BUTTOCK). FURTHER THE SURGEON REPORTED: "THE ROD MOVED DOWN TO THE BUTTOCK. THE PATIENT UNDERWENT A NEW SURGERY FOR REMOVAL IN ANOTHER HOSPITAL." (THE HOSPITAL WHERE THE REMOVAL WAS DONE WAS IN PRIVATE HOSPITAL (B)(6). COMPLAINT INVESTIGATION: THE SALES AGENT (LIONEL SIMON) HAVE UNDERSTOOD FROM INTERVIEWING THE SURGEONS THAT "IT SEEMS THAT THE PATIENT TOOK TIME TO VISIT SEVERAL SURGEONS IN LYON, AT LEAST 2, BEFORE CHOOSING, AND IT TOOK A
Patient problems: Arrhythmia
MAUDE report 22300837 ↗
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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