Pagoda 158-3500-01ARecalls & reported problems
Ortho Development Corporation · Diameter 5.5 mm x 500 mm Straight Rod One Stripe Ti · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00822409019915), received between Nov 14, 2018 and Jan 16, 2023 — classified as 4 injuries.
The most frequently reported specific device problem is “Fracture” (4 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 18, 2026.
Most reported problems
Device problems
- Fracture4
Patient problems
- Pain2
- Insufficient Information1
- No Code Available1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJan 16, 2023Fracture; Fracture
A SPINAL SURGERY WAS PERFORMED ON (B)(6) 2021 FIXING THE SPINAL COLUMN WITH BILATERAL RODS FROM T8 TO L3 WITH ONE VERTEBRA SKIPPED DUE TO TUBERCULOUS PYROGENIC SPONDYLITIS. BONE FUSION WAS DIFFICULT DUE TO THE INFECTION. SUBSEQUENTLY, BOTH RODS BROKE. ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED TO REPLACE THE RODS. THE SURGEON NOTED THAT THERE WAS NO LOOSENING OF THE SCREWS AND THE RODS WERE HEAVILY LOADED.
Patient problems: Insufficient Information
MAUDE report 16174575 ↗InjuryJun 16, 2020Fracture; Fracture
A SPINAL SURGERY WAS PERFORMED ON (B)(6) 2019 FIXING THE SPINAL COLUMN FROM L2 TO SAI. ON (B)(6) 2019, AN X-RAY CONFIRMED THAT THE LEFT AND RIGHT RODS WERE BROKEN AT L4/5. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO REPLACE THE RODS. THIS IS REPORT TWO OF TWO FOR THE SECOND OF THE TWO RODS.
Patient problems: Pain
MAUDE report 10160294 ↗InjuryJun 16, 2020Fracture; Fracture
A SPINAL SURGERY WAS PERFORMED ON (B)(6) 2019 FIXING THE SPINAL COLUMN FROM L2 TO SAI. ON (B)(6) 2019, AN X-RAY CONFIRMED THAT THE LEFT AND RIGHT RODS WERE BROKEN AT L4/5. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO REPLACE THE RODS. THIS IS REPORT ONE OF TWO FOR THE FIRST OF THE TWO RODS.
Patient problems: Pain
MAUDE report 10160277 ↗InjuryNov 14, 2018Fracture; Fracture
A PATIENT RECEIVED L4 SPINAL FUSION SURGERY ON (B)(6) 2017. AFTER THE OPERATION, THE ROD WAS BROKEN. ON (B)(6) 2017, THE PATIENT WAS REVISED AND THE ROD WAS REPLACED. ON (B)(6) 2017, THE PATIENT WAS REPORTED TO BE RECOVERING SMOOTHLY.
Patient problems: No Code Available
MAUDE report 8070508 ↗
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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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