OsseoScrew 53065-40Recalls & reported problems
Alphatec Spine, Inc. · OSSEOSCREW F TI POLYAXIAL 6.5 X 40MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844856049123), received between Feb 24, 2021 and Mar 25, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break2
- Entrapment of Device1
- Fracture1
Patient problems
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2021Break
THE TIP OF AN OSSEOSCREW BROKE OFF WHILE REMOVING IT DURING A REVISION SURGERY. THE DETACHED SECTION WAS UNABLE TO BE REMOVED FROM THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 11569310 ↗MalfunctionFeb 24, 2021Break; Entrapment of Device; Fracture
ON (B)(6) 2021 REVISION SURGERY WAS CONDUCTED REMOVING A PREVIOUSLY IMPLANTED CONSTRUCT IN ORDER TO PERFORM AN OSTEOTOMY. DURING THE SCREW REMOVAL, THE DISTAL EXPANSION SECTION OF THE OSSEOSCREW FRACTURE AND BROKE. THE DETACHED SECTION REMAINING ENTRAPPED WITHIN THE PATIENTS RIGHT L5. THE OSSEOSCREW SPINAL FIXATION SYSTEM WAS ORIGINALLY IMPLANTED (B)(6) 2020.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 11372314 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page