Cannulated Tapered Pedicle Screw 88689Recalls & reported problems
Premia Spine Ltd · Cannulated Tapered Pedicle Screw 7.5X45[mm] used for fixation of spinal implants to the vertebrae. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290115933895), received between Oct 21, 2024 and Oct 21, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
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.
MalfunctionOct 21, 2024Fracture; Fracture
DURING AN IMPLANTATION OF THE TOPS SYSTEM IN THE US, THE SURGEON USED A MALLET TO HAMMER ON THE TORQUE LIMITER CONNECTED TO THE PEDICLE SCREW AND THEN PERFORMED A FINAL TIGHTENING WITHOUT THE COUNTER TORQUE. DURING THE FINAL TIGHTENING, A PORTION OF THE PEDICLE SCREW TULIP BROKE OFF. THE SURGEON INDICATED TO THE COMPANY'S REPRESENTATIVE DURING THE SURGERY THAT HIS INCISION WAS TOO SMALL TO USE THE COUNTER TORQUE. AN ADEQUATE MIDLINE INCISION IS REQUIRED TO PERFORM THE ENTIRE PROCEDURE CORRECTLY, INCLUDING PLACING THE COUNTER TORQUE, AS DESCRIBED IN THE PRODUCT LABELING. THE INVOLVED SCREW WAS REMOVED AND REPLACED WITH SAME SIZE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20490903 ↗
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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