Neo Pedicle Screw System SC-80-90-ILRecalls & reported problems
Neo Medical SA · Iliac screw Ø8.0 x 90mm · 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 07640177820730), received between Oct 24, 2024 and Oct 24, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Material Integrity 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 24, 2024Material Integrity Problem; Material Integrity Problem
EVENT DESCRIPTION: IN (B)(6) 2024, A POLYTRAUMA SURGERY INVOLVING L1-ILIAC FIXATION WAS PERFORMED AT (B)(6) (GERMANY). COMPLICATION AROSE AFTER SURGERY, AN ILIAC SCREW BROKE ON ONE SIDE, AND THE SET-SCREW LOOSENED ON THE CONTRALATERAL SIDE, WE DO NOT KNOW EXACT DATES WHEN THE BREAKAGE HAPPENED. THE BREAKAGE OCCURRED AT THE NECK OF THE ILIAC SCREW. NEO MEDICAL DID NOT RECEIVE THE EXPLANTS HOWEVER WE RECEIVED MRI SCAN IMAGES SHOWING THE BREAKAGE AND THE SET SCREW LOOSENING. FROM THE MRI IMAGE IT IS CLEARLY VISIBLE THAT THE SURGEON DID NOT APPLY ACCURATE BENDING TO THE RODS AND THEREFORE HAD TO FORCE THE SCREW TO CONNECT IT TO THE ROD. IN (B)(6) 2024, ANOTHER SURGEON SUCCESSFULLY REMOVED THE BROKEN ILIAC SCREW SHAFT. RODS WERE BENT TO AVOID APPLYING UNWANTED FORCES TO CONNECT THE ROD AND THE ILIAC SCREWS. THIS CAN BE SEEN WHEN COMPARING CORONAL ROD BENDING ON AP VIEW BETWEEN THE PRE-OP MRI WITH BROKEN IMPLANT (RODS ARE ALMOST STRAIGHT) VS. THE INTRA-OP X-RAYS (WITH MARKED SAGITTAL AND CORONAL BENDING BETWEEN L5 AND ILIAC SCREW). THE SURGEON RECOGNIZED THAT THE ROD BENDING IN THE INITAL SURGERY WAS NOT IDEAL AND COULD BE THE MAIN REASON FOR THE BREAKAGE. COMPLAINT INVESTIGATION: NEO ME
Patient problems: Failure of Implant
MAUDE report 20521791 ↗
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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