Response 4.5/5.0 Spine System 00-1600-5055Recalls & reported problems
Orthopediatrics Corp. · 5.0 ROD, COCR, SINGLE HEX 500 MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841132150603), received between Sep 17, 2025 and Sep 17, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2025Fracture; Fracture
DR. (B)(6) FROM (B)(6) REPORTED A POST-OPERATIVE ISSUE INVOLVING A 17-YEAR-OLD MALE PATIENT WITH CEREBRAL PALSY, IMPLANTED WITH TWO 5.0 COCR RODS (PART NO. 00-1600-5055) FROM THE RESPONSE 4.5/5.0 SYSTEM. ONE ROD WAS PREVIOUSLY NOTED AS BROKEN BUT LEFT IN PLACE DUE TO THE PATIENT'S STABLE CONDITION. THE PATIENT LATER PRESENTED WITH A WOUND, AND IMAGING REVEALED BOTH RODS WERE BROKEN, WITH THE SECOND ROD CAUSING THE INJURY. THE BREAKAGE OCCURRED AT A NON-FUSED SECTION OF THE SPINE. THE ORIGINAL IMPLANT DATE WAS (B)(6) 2023.
Patient problems: Failure of Implant
MAUDE report 23077267 ↗
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- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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