OsseoScrew 53165-50Recalls & reported problems
Alphatec Spine, Inc. · OSSEOSCREW F TI HIGH TOP 6.5 X 50MM · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844856049062), received between Feb 16, 2021 and Jul 30, 2021 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
- Fracture1
- Output Problem1
- Physical Resistance/Sticking1
Patient problems
- Insufficient Information2
- Failure of Implant1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 30, 2021Output Problem; Physical Resistance/Sticking
AFTER REMOVING A SCREW, THE SURGEON WAS UNABLE TO DECOMPRESS THE EXPANSION AREA BECAUSE THE TULIP WAS LOCKED IN PLACE.
Patient problems: Insufficient Information
MAUDE report 12255865 ↗MalfunctionMar 3, 2021Break
DURING A SCHEDULED 9 MONTH FOLLOW UP APPOINTMENT ON (B)(6) 2021 X-RAYS DISCOVERED A BROKEN OSSEOSCREW. THE OSSEOSCREW SPINAL FIXATION SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2020.
Patient problems: Failure of Implant
MAUDE report 11406298 ↗MalfunctionFeb 16, 2021Fracture
WHILE ATTEMPTING TO COLLAPSE AND REMOVE EXPANDED OSSEOSCREWS, BOTH SCREWS FRACTURED IN SITU. THE SURGEON ATTEMPTED TO USE THE REMOVAL TOOL BUT WAS UNABLE TO THREAD THE TOOL INTO THE DISTAL TIP OF THE SCREW TO RETRIEVE THE IMPLANTS. THE OSSEOSCREW SPINAL FIXATION WAS IMPLANTED ON (B)(6) 2020
Patient problems: Insufficient Information
MAUDE report 11335759 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.