CarboClear Pedicle Screw System Pedicle Screw - Non Cannulated (REF PNNS5545)Recalls & reported problems
Carbofix Orthopedics Ltd · Non cannulated pedicle screw (oncology) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07290110200640), received between Jul 4, 2019 and Jun 18, 2020 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 reports).
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.
Most reported problems
Device problems
- Fracture3
- Detachment of Device or Device Component1
Patient problems
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2020Fracture; Fracture
DURING A SURGERY WITH THE CARBOCLEAR PEDICLE SCREW SYSTEM, FOR THE TREATMENT OF ONCOLOGICAL PATIENT, A SCREW BROKE WHILE BEING INSERTED INTO THE PEDICLE; THE SCREW WAS REMOVED AND SURGERY WAS SUCCESSFULLY COMPLETED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10166994 ↗MalfunctionJan 7, 2020Fracture; Fracture
DURING FIXATION OF T6-T11 VERTEBRAE OF ONCOLOGICAL PATIENT IN (B)(6), ONE OF THE SCREWS AT T9 WAS INSERTED IN A MANNER THAT THE SCREW TULIP TOUCHED THE PEDICLE. THIS CAUSED SIGNIFICANT RESISTANCE THAT LED TO EXCESSIVE TORQUE AND BREAKAGE OF THE SCREW. THE PHYSICIAN DECIDED THE CONSTRUCT IS STRONG ENOUGH (LEAVING THE SCREW IN SITU, WITH FIXATION OF TWO LEVELS ABOVE AND TWO LEVELS BELOW THE AFFECTED VERTEBRAE).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9556734 ↗MalfunctionJul 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
DURING A SURGERY IN (B)(6), A PEDICLE SCREW DISASSEMBLED (THE "TULIP" DISCONNECTED FROM THE SCREW); THE SCREW WAS GRIPPED BY A PLIER AND REMOVED (UNSCREWED).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8761996 ↗MalfunctionJul 4, 2019Fracture; Fracture
DURING A SURGERY WITH THE CARBOCLEAR PEDICLE SCREW SYSTEM IN (B)(6), FOR THE TREATMENT OF ONCOLOGICAL PATIENT, A SCREW BROKE WHILE BEING INSERTED INTO THE PEDICLE; THE SCREW WAS SUCCESSFULLY REMOVED WITH A DRILL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8761995 ↗
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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