Pagoda 752-7545-11ARecalls & reported problems
Ortho Development Corporation · Diameter 7.5 mm x 45 mm Polyaxial Screw · Class 2 · Implant
Data updated Oct 18, 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 00822409022519), 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 18, 2026.
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Death1
- Pain1
- Patient Problem/Medical Problem1
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 1 OF 2.
Patient problems: Death; Pain; Patient Problem/Medical Problem
MAUDE report 7891960 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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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