Response Spine 5.5/6.0 System 00-1300-2640Recalls & reported problems

Orthopediatrics Corp. · 5.5/6.0 POLYAXIAL PEDICLE SCREW 6.0MM X 40MM · 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: 6
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841132101315), received between Jan 14, 2025 and Apr 28, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fracture6

Patient problems

No Clinical Signs, Symptoms or Conditions4
Failure of Implant1
Insufficient Information1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 28, 2026Fracture
ON (B)(6) 2026, A COMPLAINT WAS REPORTED INVOLVING (6.5 X 40 POLY, PART NUMBER 00-1300-2640; 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 25015746 ↗
MalfunctionNov 12, 2025Fracture; Fracture
PATIENT UNDERWENT PSF FOR AIS. SUSPECT SCREW FRACTURE NOTED ON FOLLOW UP IN 2023 WITH NO SYMPTOMS AND NO REPORT FROM TREATING CLINICIAN. OBVIOUS SCREW FRACTURE NOTED ON FINAL FOLLOW UP (TODAY) PATIENT REMAINED UN-SYMPTOMATIC AND DISCHARGED FROM SURGEON CARE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23533167 ↗
MalfunctionAug 7, 2025Fracture; Fracture
DR. (B)(6) AT (B)(6) REPORTED A POST-OPERATIVE ISSUE INVOLVING A 6.0X40 POLY PEDICLE SCREW (PART NUMBER 00-1300-2640) FROM THE RESPONSE 5.5_6.0 SCOLIOSIS SYSTEM. THE NON-STERILE, CONSIGNED DEVICE WAS IMPLANTED ON (B)(6) 2024, AND WAS LATER FOUND BROKEN AT THE SHANK DURING A ONE-YEAR FOLLOW-UP IN THE CLINIC. DESPITE THE BREAKAGE, THERE WAS NO PATIENT INJURY, NO DELAY IN SURGERY, AND NO NEED FOR REVISION; THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE BROKEN PIECE REMAINS INSIDE THE PATIENT, AND NO PRODUCT WAS RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22742785 ↗
MalfunctionFeb 24, 2025Fracture; Fracture
PATIENT PRESENTED TO CLINIC WITH BROKEN SCREW AT BOTTOM OF CONSTRUCT T12. CONSTRUCT IS T-T12 WITH 6.0 COCR RODS ON BOTH LEFT AND RIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21447763 ↗
MalfunctionFeb 24, 2025Fracture; Fracture
PATIENT PRESENTED TO CLINIC WITH BROKEN SCREW AT L1 THE BOTTOM OF THE CONSTRUCT. CONSTRUCT IS T2-L1 USING A 6.0 COCR ROD ON THE LEFT AND 6.0 TI ROD ON RT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21447723 ↗
MalfunctionJan 14, 2025Fracture; Fracture
T5-L1 INSTRUMENTED SPINAL FUSION FOR SCOLIOSIS ON (B)(6) 2023) FOLLOW UP CLINIC IN 2024, L1 PEDICLE SCREW SHANK NOTED BE TO BE FRACTURED. IMPLANT FRACTURED.
Patient problems: Insufficient Information
MAUDE report 21147667 ↗

Device details

UDI-DI	`00841132101315`
Brand	Response Spine 5.5/6.0 System
Model	00-1300-2640
Company	Orthopediatrics Corp.
Product code	MNI · ORTHOSIS, SPINAL PEDICLE FIXATION
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 10, 2025

Device type (GMDN): Spinal bone screw, non-bioabsorbable

A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Other ORTHOSIS, SPINAL PEDICLE FIXATION devices

NA 04.614.508
Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION
277 reports
CREO 1134.0010
Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
112 reports
CREO 1119.0010
Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
80 reports
VIPER 186731745
Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION
43 reports
CD HORIZON® Spinal System 1553201090
Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
38 reports
EXPEDIUM 179902000
Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION
37 reports
CD HORIZON® Spinal System 7540220
Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
36 reports
EXPEDIUM VERSE 199721640
Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION
35 reports

All ORTHOSIS, SPINAL PEDICLE FIXATION devices →

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.

How reports and recalls are matched · Editorial policy · Report an error on this page