Pagoda 752-7550-11ARecalls & reported problems
Ortho Development Corporation · Diameter 7.5 mm x 50 mm Polyaxial Screw · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822409022564), received between Sep 19, 2018 and Sep 19, 2018 — classified as 1 death.
The most frequently reported specific device problem is “Use of Device Problem” (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
- Use of Device Problem1
Patient problems
- Death1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathSep 19, 2018Use of Device Problem; Use of Device Problem
ON (B)(6) 2018, A REVISION SURGERY WAS PERFORMED TO EXTEND EXISTING L4-L5 PEDICLE SCREW FIXATION TO L3-S1. THE SURGERY ALSO INVOLVED VERTEBROPLASTY OF L5 TOGETHER WITH L5-S1 TLIF USING ANOTHER MANUFACTURER'S CAGE. DURING SURGERY, THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP AND THE PATIENT EXPIRED. THE REPORT INDICATED THE PATIENT'S LEFT ILIAC ARTERY WAS MOST LIKELY PERFORATED WHEN PUSHING THE ROD ONTO THE SCREW. THE SURGEON STATED THIS INCIDENT WAS DUE TO A TECHNICAL ERROR AND NOT THE PEDICLE SCREW. TWO PEDICLE SCREWS WERE IN USE BUT IT IS UNKNOWN WHICH SCREW WAS INVOLVED SO TWO IDENTICAL MEDWATCH REPORTS ARE BEING FILED, ONE FOR EACH PART NUMBER. THIS IS REPORT 2 OF 2.
Patient problems: Death; Pain
MAUDE report 7892017 ↗
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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