DIAPASON 665480Recalls & reported problems
Stryker Corporation · ROD · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540383587), received between Feb 3, 2017 and Feb 3, 2017 — classified as 1 injury, 1 malfunction.
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
- Fracture2
- Material Integrity Problem2
Patient problems
- Pain2
- Failure of Implant1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
IT WAS REPORTED THAT; "PATIENT UNDERWENT SURGERY ON (B)(6) 2009 WHERE SHE WAS IMPLANTED WITH SPINAL SYSTEM, INCLUDING THE ROD. THE ROD WAS PLACED ON EITHER SIDE OF THE PATIENT'S SPINE BETWEEN L3 AND S1. RECORDS OF THE SURGICAL PROCEDURE ARE ATTACHED. ON (B)(6) 2016, FOLLOWING YEARS OF CONTINUED LOWER BACK PAIN, THE PATIENT UNDERWENT A LUMBAR SPINE CT SCAN THAT SHOWED THE TITANIUM RODS ARE BROKEN AT THE L5 LEVEL."
Patient problems: Pain
MAUDE report 6301349 ↗InjuryFeb 3, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
IT WAS REPORTED THAT; "PATIENT UNDERWENT SURGERY ON (B)(6) 2009 WHERE SHE WAS IMPLANTED WITH SPINAL SYSTEM, INCLUDING THE ROD. THE ROD WAS PLACED ON EITHER SIDE OF THE PATIENT'S SPINE BETWEEN L3 AND S1. ON (B)(6) 2016, FOLLOWING YEARS OF CONTINUED LOWER BACK PAIN, THE PATIENT UNDERWENT A LUMBAR SPINE CT SCAN THAT SHOWED THE TITANIUM RODS ARE BROKEN AT THE L5 LEVEL."
Patient problems: Failure of Implant; Pain
MAUDE report 6301342 ↗
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- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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