Response Spine 5.5/6.0 System 00-1300-7640Recalls & reported problems
Orthopediatrics Corp. · 5.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 40mm 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
- 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 00841132131299), received between Nov 16, 2024 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
Most reported problems
Device problems
- Fracture6
Patient problems
- Failure of Implant3
- No Clinical Signs, Symptoms or Conditions2
- 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 00-1300-7640; 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 25015845 ↗MalfunctionMar 2, 2026Fracture
MalfunctionDec 3, 2025Fracture; Fracture
TWO BROKEN 6.5 X 40 POLY PEDICLE SCREWS AT BOTTOM OF THE CONSTRUCT.
Patient problems: Failure of Implant
MAUDE report 23707591 ↗MalfunctionAug 7, 2025Fracture; Fracture
DR. (B)(6) AT (B)(6) HOSPITAL REPORTED A POST-OPERATIVE ISSUE INVOLVING A 6.5X40MM POLY PEDICLE SCREW (PART NUMBER 00-1300-7640) 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 INSIDE THE PATIENT DURING A CLINIC VISIT 10 MONTHS POST-OP. DESPITE THE BREAKAGE, THERE WAS NO PATIENT INJURY, SURGICAL DELAY, OR NEED FOR REVISION, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE BROKEN SCREW REMAINS INSIDE THE PATIENT, AND NO PRODUCT IS AVAILABLE FOR RETURN OR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22742839 ↗MalfunctionMar 17, 2025Fracture; Fracture
BROKEN 6.5X40MM POLY PEDICLE SCREW WITH 5.5 COCR ROD AND 5.5 TI ROD. STILL IMPLANTED WITH ASYMPTOMATIC PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21621887 ↗MalfunctionNov 16, 2024Fracture; Fracture
PATIENT PRESENTED APPROXIMATELY 14 MONTHS POST OP WITH BROKEN SCREW BILATERALLY AT THE DISTAL END ON CONSTRUCT (T12). FUSION WAS NOT ACHIEVED SO WAS FORCED TO BRING BACK TO OR, REMOVE BROKEN SCREW AND EXTEND FUSION 1 LEVEL LOWER (L1) WHILE ALSO REPLACING RODS BILATERALLY.
Patient problems: Insufficient Information
MAUDE report 20701795 ↗
Other Pedicle screw spinal system, adolescent idiopathic scoliosis devices
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- EXPEDIUM 179762480Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis114 reports
- ReLine 13550000Nuvasive, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis55 reports
- CD HORIZON® Spinal System 5440030Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis50 reports
- EXPEDIUM 179712640Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis28 reports
- EXPEDIUM 179788635Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis18 reports
- EXPEDIUM VIPER 196789300Depuy Spine, LLC · Pedicle screw spinal system, adolescent idiopathic scoliosis18 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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