TALKEETNA 5.5 Lumbar Pedicle Screw System TPS1-55-37545Recalls & reported problems
Kahtnu Surgical · TALKEETNA 5.5 Multi Axial Screw 7.5 x 45mm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B644TPS155375450), received between Aug 29, 2019 and Oct 22, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Mechanical Problem” (2 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
- Mechanical Problem2
Patient problems
- Discomfort2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 22, 2019Mechanical Problem; Mechanical Problem
PATIENT PRESENTED WITH A COMPLAINT OF BACK PAIN. PLAIN FILM X-RAYS AND A CT SCAN REVEALED A FAILED FUSION. A REVISION SURGERY WAS SCHEDULED AND COMPLETED ON (B)(6) 2019. DURING THE REVISION SURGERY IT WAS DISCOVERED THAT ONE OF THE SCREWS HAD BROKEN.
Patient problems: Discomfort
MAUDE report 9221431 ↗InjuryAug 29, 2019Mechanical Problem; Mechanical Problem
PATIENT PRESENTED WITH A COMPLAINT OF BACK PAIN. PLAIN FILM X-RAYS REVEALED A BROKEN SCREW AT THE S1 LEVEL. REVISION SURGERY PLANNED TO REMOVE BROKEN HARDWARE AND REPLACE.
Patient problems: Discomfort
MAUDE report 8947850 ↗
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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