Cannulated Tapered Pedicle Screw 88691Recalls & reported problems
Premia Spine Ltd · Cannulated Tapered Pedicle Screw 7.5X55[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 07290115933918), received between Sep 17, 2024 and Sep 17, 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.
MalfunctionSep 17, 2024Fracture; Fracture
THE COMPANY RECEIVED A REPORT THAT A PEDICLE SCREW TULIP BROKE DURING A SURGICAL PROCEDURE. FOLLOWING PEDICLE SCREW INSERTION, SET SCREWS WERE PLACED IN TULIPS. THE SURGEON STOOD ON PATIENT'S RIGHT SIDE AND ASSEMBLED COUNTER-TORQUE AND TORQUE LIMITER ON THE NEAREST TULIP, SLIDING COUNTER-TORQUE UP TO VISUALIZE THE TORQUE LIMITER'S DISTAL TIP. ATTEMPTS TO PLACE TORQUE LIMITER TIP INTO L4 RIGHT SET SCREW WERE DIFFICULT. A MALLET WAS USED TO HAMMER THE HANDLE OF TORQUE LIMITER TO DEEPEN THE TIP INTO THE SET SCREW. DEPTH OF TIP COULD NOT BE CONFIRMED AFTER MALLETING. WHEN THE FINAL TIGHTENER WAS TURNED ON FIRST SET SCREW, A LOUD POP WAS HEARD IN CONJUNCTION WITH THE SET SCREW FLYING ACROSS ROOM AND THE SIDEWALL OF TULIP LAYING ON OPERATING TABLE. THE SURGEON WAS LEANING BACK DURING THE TIGHTENING PROCESS. THIS CIRCUMSTANCE COULD ONLY HAPPEN IF THE COUNTER TORQUE WAS NOT LOCKED ON THE ROD AND SEATED OVER THE TULIP DURING THE TIGHTENING PROCESS. THE L4 RIGHT SCREW WAS REMOVED AND REPLACED WITH SAME SIZE SCREW (7.5X55MM). FUSION RODS AND SET SCREWS WERE PLACED AND THE SET SCREW INSERTER WAS USED TO TIGHTEN THE SET SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20240505 ↗
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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