Response Rib and Pelvic System 00-1600-5000Recalls & reported problems

Orthopediatrics Corp. · 4.5/6.0 RIB HOOK CLAMP · 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 00840194422024), received between Nov 6, 2025 and Nov 6, 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

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

Most reported problems

Device problems

Fracture1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 6, 2025Fracture; Fracture
SURGEON STRIPPED A RIB HOOK CLAMP SCREW AND IT BROKE IN HALF INSIDE THE RIB HOOK. SURGEON HAD TO TAKE CONSTRUCT APART WHEN DONE TO REPLACE THE RIB HOOK AND CLAMP. THIS CAUSED A DELAY GREATER THAN 30 MINS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23490783 ↗

Device details

UDI-DI	`00840194422024`
Brand	Response Rib and Pelvic System
Model	00-1600-5000
Company	Orthopediatrics Corp.
Product code	MDI · Prosthesis, rib replacement
Class	Class 2
FDA submission	K233105
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Feb 2, 2024

Device type (GMDN): Vertical expandable prosthetic rib system

An assembly of implantable devices designed to treat a patient with complex chest wall and/or spinal deformities, typically thoracic insufficiency syndrome (TIS) in paediatric patients (a congenital condition where severe deformities of the chest, spine, and ribs prevent normal breathing and lung growth and development). The assembly typically consists of telescoping rods/bars, fixation hooks, and locking screws/clamps made of surgical stainless steel or titanium (Ti), and are typically vertically attached to the ribs, spine, and/or pelvis to help straighten the spine and separate ribs so that the lungs can grow and fill with sufficient air for breathing.

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All Prosthesis, rib replacement 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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