Response Spine 5.5/6.0 System 00-1300-0645Recalls & reported problems

Orthopediatrics Corp. · 5.5/6.0 UNIAXIAL 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: 4
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841132100332), received between Jun 5, 2019 and Sep 17, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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

Fracture4

Patient problems

Failure of Implant2
No Clinical Signs, Symptoms or Conditions1
No Information1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 17, 2025Fracture; Fracture
DR (B)(6) FROM CHICAGO SHRINE REPORTED AN ISSUE INVOLVING A 12-YEAR-OLD FEMALE PATIENT IMPLANTED WITH A 6.0 UNI PEDICLE SCREW (PART NO. 00-1300-0645) FROM THE RESPONSE 5.5/6.0 SPINE SYSTEM. DURING A 12-MONTH FOLLOW-UP, TWO SCREWS WERE FOUND BROKEN AT THE BOTTOM OF THE CONSTRUCT. THE EVENT RESULTED IN A REVISION PROCEDURE. THE AFFECTED DEVICE WAS REMOVED ON (B)(6) 2025. NO PATIENT INJURY OR DEATH WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 23077538 ↗
MalfunctionJun 22, 2025Fracture; Fracture
BROKEN PEDICLE SCREWS FOUND AT 1 YEAR POST-OPERATIVE APPOINTMENT. PATIENT TO UNDERGO REMOVAL/REVISION SURGERY WITHIN THE NEXT MONTH. TENTATIVELY SCHEDULED FOR (B)(6) 2025.
Patient problems: Failure of Implant
MAUDE report 22304836 ↗
MalfunctionFeb 24, 2025Fracture; Fracture
PATIENT PRESENTED TO CLINIC WITH BROKEN SCREW AT THE BOTTOM LEVEL OF THE CONSTRUCT L3. CONSTRUCT IS T11-L3 UTILIZING 5.5 COCR RODS ON BOTH SIDES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21447756 ↗
InjuryJun 5, 2019Fracture; Fracture
IT WAS REPORTED THAT FOLLOWING THE PLACEMENT OF A RESPONSE SPINE CONSTRUCT, IT WAS FOUND THAT A SCREW FRACTURED ON THE RIGHT SIDE AT L3. THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE THE FRACTURED SCREW AND TO EXTEND THE CONSTRUCT TO L4. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Information
MAUDE report 8671958 ↗

Device details

UDI-DI	`00841132100332`
Brand	Response Spine 5.5/6.0 System
Model	00-1300-0645
Company	Orthopediatrics Corp.
Product code	NKB · Orthosis, spinal pedicle fixation, for degenerative disc disease
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.

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All Orthosis, spinal pedicle fixation, for degenerative disc disease 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.

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