Neo Medical Pedicle screw kit RD-00-40-PBRecalls & reported problems
Neo Medical SA · Rod kit pre-bent 40 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 07640177820181), received between Apr 2, 2025 and Apr 2, 2025 — classified as 1 injury.
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.
InjuryApr 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
EVENT DESCRIPTION: SET SCREW LOOSENING AND ROD SLIPPAGE (DISCONNECTION BETWEEN THE TULIP AND THE ROD) OCCURRED A FEW WEEKS POST OP (ORIGINAL POST OP ABOVE AND 3 WEEK POST OP BELOW) ON ONE SIDE OF A L2/L3 LLIF FUSION WITH POSTERIOR FIXATION. AFTER REVIEW, IT IS EXPECTED THAT THE ROD USED FOR THE SEGMENT WAS 5MM TOO SHORT. COMPLAINT INVESTIGATION: NEO MEDICAL GATHERED THE FOLLOWING INFORMATION BY INTERVIEWING SURGEONS AND SALES REP: "A TOO SHORT ROD WAS USED". THIS TYPE OF ISSUE IS KNOWN AND DISPLAYED IN THE SURGICAL TECHNIQE WITH A FEW MM OVERHANG IS DESCRIBED. BY ANALYSING THE MRI AND X-RAYS IMAGES WE CAN CONCLUDE THAT FROM MEASURING THE OVERHANG A 0.5MM DIFFERENCE ON ONE SIDE OF THE ROD CAUSED ONE SIDE TO SLIP (1.5MM OVERHANG) WHILE THE OTHER SIDE DID NOT (2.0 MM OVERHANG). NEO MEDICAL ALSO LOOKED AT THE BATCH PRODUCTION RECORDS FOR THE AFFECTED LOTS, THE REPORT CONCLUDED NO RELEVANT DEVIATIONS RELATED TO PRODUCT QUALITY. THE MOST PROBABLE ROOT CAUSE OF THE FAILURE WAS THAT THE ROD USED WAS TOO SHORT RESULTING DUE TO A LACK OF CONTACT POINT BETWEEN ROD AND SCREW HEAD ("THE TULIP") RESULTING IN A DISCONNECTION OF THE CONSTRUCT. THIS IS THE FIRST TIME THAT A TOO SHORT ROD HAVE BEEN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21758861 ↗
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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