Response Spine 5.5/6.0 System 00-1300-7645Recalls & reported problems
Orthopediatrics Corp. · 5.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 45mm Length · Class 2 · Implant
All models of Response Spine 5.5/6.0 System (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841132131305), received between Nov 25, 2025 and Apr 28, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2026Fracture
A COMPLAINT WAS REPORTED INVOLVING (6.5 X 45 POLY, PART NUMBER 00-1300-7645; USED IN A SCOLIOSIS PROCEDURE AT (B)(6) HOSPITAL. THE ISSUE WAS IDENTIFIED IN THE CLINIC/POST-OPERATIVE SETTING. THE SURGEON REPORTED THAT THE SCREW AT THE BOTTOM OF THE CONSTRUCT HAD BROKEN, NECESSITATING A REVISION PROCEDURE.
Patient problems: Failure of Implant
MAUDE report 25015640 ↗MalfunctionNov 25, 2025Fracture; Fracture
BROKEN POLY PEDICLE SCREWS. CAUSED PAIN AND HAD TO REVISE.
Patient problems: Failure of Implant
MAUDE report 23648619 ↗
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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