Response Spine 5.5/6.0 System 00-1300-2645Recalls & reported problems
Orthopediatrics Corp. · 5.5/6.0 POLYAXIAL PEDICLE SCREW 6.0MM X 45MM · 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841132101322), received between Nov 22, 2024 and Feb 24, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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
- Fracture3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2025Fracture; Fracture
PATIENT PRESENTED TO CLINIC WITH BROKEN SCREW AT BOTTOM LEVEL OF CONSTRUCT L1. CONSTRUCT IS T3-L1 USING 6.0 COCR ON LEFT AND 6.0 TI ON RT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21447760 ↗MalfunctionFeb 24, 2025Fracture; Fracture
PATIENT PRESENTED WITH BROKEN SCREWS AT BOTTOM LEVEL L3 OR CONSTRUCT. CONSTRUCT IS T5-L3. NO REVISION PROCEDURE IS SCHEDULED AT THIS TIME AS PATIENT DOESN'T HAVE ANY SYMPTOMS AND CURVE HAS NOT PRORGRESSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21447729 ↗MalfunctionNov 22, 2024Fracture; Fracture
BROKEN PEDICLE SCREW WERE LOCATED AT THE LOWEST INSTRUMENTED LEVEL L1.
Patient problems: Insufficient Information
MAUDE report 20765596 ↗
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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