Neo Pedicle Screw System SC-80-50-PERecalls & reported problems
Neo Medical SA · Pedicle screw kit 2x(Ø8.0 x 50mm) · 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 07640177820693), received between Aug 9, 2024 and Aug 9, 2024 — 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
- Implant Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
EVENT DESCRIPTION: REVISION SURGERY PERFORMED ON (B)(6) 2024 AFTER 10 MONTHS FROM INITIAL SURGERY DUE TO PAIN AND DISCONNECTED OF THE SCREW HEAD FROM THE SCREW SHAFT ON THE LEVEL L5 ON BOTH SIDES. A SECOND SURGERY TOOK PLACE AFTER THE REVISION SURGERY TO IMPLANT AN INTERBODY FUSION CAGE ON L4 V INITIAL SURGERY PERFORMED ON (B)(6) 2023 WITH MONOAXIAL SCREWS SC-80-50-PE (ON LEVEL L4 SC-80-55-PE (2021046031) AND RD-00-90-PB (2020035136)). COMPLAINT INVESTIGATION: THE X-RAY AFTER THE FIRST SURGERY IN (B)(6) 2023 LOOKS FINE (NO SCREW BREAKAGE OR DISCONNECTION). THE PATIENT WAS SUPPOSED TO GET A FOLLOW-UP VISIT SCHEDULED AT 6 WEEKS FOR X-RAY CONTROL BUT HE DID NOT SHOW UP. AT THAT TIME THE SURGEON ALSO PLANNED A SECOND SURGERY TO ADD THE ANTERIOR SUPPORT SURGERY (ADDING A CAGE). ONLY AFTER 10 MONTHS THE PATIENT CAME TO THE HOSPITAL WITH PAIN AND THE PROBLEM LEADING TO A THE FIRST REVISION SURGERY. NO FUSION COULD BE SEEN AT THE 10 MONTH X-RAY. IN CASE A CAGE IS NOT PLACED A FUSION WILL NOT OCCUR. AS STATED IN IFU FOR NEO PEDICLE SCREW SYSTEM: "THE NEO PEDICLE SCREW SYSTEM¿ IS INTENDED TO HELP PROVIDE IMMOBILIZATION, CORRECTION AND STABILIZATION OF SPINAL SEGMENTS AS AN ADJUNCT TO FUSION
Patient problems: Implant Pain
MAUDE report 19949667 ↗
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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