PASS LP B02216545Recalls & reported problems
Medicrea International · POLYAXIAL PEDICLE SCREW Ø 6.5mm x 45mm · Class 2
All models of PASS LP (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03613720177586), received between Nov 26, 2021 and Nov 26, 2021 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 26, 2021Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L3/L4 MATERIAL ABLATION FOR AN INDICATION OF INFECTION. IT WAS REPORTED THAT DURING THE LOCKING OF THE LEFT SCREW AT THE BOTTOM L4, THE SCREW EXTENSION BROKE BEFORE THE NUT, CAUSING THE SCREW TO FALL OUT OF THE PEDICLE. THE EXTENSION FAILURE PUSHED THE SCREW LATERALLY AND IT CAUSED A PEDICLE FRACTURE. THE SURGEON HAD TO REMOVE ALL THE SCREWS AND NO MORE IMPLANT POSSIBLE ON THIS LEVEL. THERE WAS NO SURGICAL DELAY REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED.
Patient problems: Bone Fracture(s)
MAUDE report 12876693 ↗
Other Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease devices
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- 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.
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