Response Spine 5.5/6.0 SystemRecalls & reported problems across all models
Orthopediatrics Corp. · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 42
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 0
We found 13 models of Response Spine 5.5/6.0 System by Orthopediatrics Corp. in the FDA's device registry (GUDID). Together they are named in 42 adverse event reports in the FDA's MAUDE database, received between Aug 30, 2017 and Jun 2, 2026 — classified as 5 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Fracture” (31 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Response Spine 5.5/6.0 System problems
Device problems
- Fracture31
- Migration4
- Detachment of Device or Device Component2
- Device Dislodged or Dislocated1
- Loose or Intermittent Connection1
- Mechanical Problem1
- Product Quality Problem1
- Use of Device Problem1
Patient problems
- Failure of Implant18
- No Clinical Signs, Symptoms or Conditions11
- Insufficient Information5
- No Information3
- Pain2
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Response Spine 5.5/6.0 System models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Response Spine 5.5/6.0 System 00-1003-4001ORTHOSIS, SPINAL PEDICLE FIXATION9 reports
- Response Spine 5.5/6.0 System 00-1300-2640ORTHOSIS, SPINAL PEDICLE FIXATION6 reports
- Response Spine 5.5/6.0 System 00-1300-7640Pedicle screw spinal system, adolescent idiopathic scoliosis6 reports
- Response Spine 5.5/6.0 System 00-1300-0640APPLIANCE, FIXATION, SPINAL INTERLAMINAL5 reports
- Response Spine 5.5/6.0 System 00-1300-0645Orthosis, spinal pedicle fixation, for degenerative disc disease4 reports
- Response Spine 5.5/6.0 System 00-1300-2645ORTHOSIS, SPINAL PEDICLE FIXATION3 reports
- Response Spine 5.5/6.0 System 00-1300-6640Orthosis, spinal pedicle fixation, for degenerative disc disease2 reports
- Response Spine 5.5/6.0 System 00-1300-7645ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- Response Spine 5.5/6.0 System 00-1300-0740APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- Response Spine 5.5/6.0 System 00-1300-1645ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- Response Spine 5.5/6.0 System 00-1300-2540Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- Response Spine 5.5/6.0 System 00-1300-6540APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- Response Spine 5.5/6.0 System 00-1300-7435APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
Recent Response Spine 5.5/6.0 System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2026Fracture
DOCTOR REMOVED TWO 5.5X40MM POLY PEDICLE SCREWS FROM L1, LEFT AND RIGHT. SCREW WAS BROKE AT THE PROXIMAL ENDS OF THE SCREW SHANK. THE BROKEN HARDWARE WAS REMOVED.
Patient problems: Failure of Implant
MAUDE report 25364723 ↗MalfunctionJun 2, 2026Migration
PATIENT PRESENTED IN CLINIC 1 YEAR POST OP AND FOUND MULTIPLE SET SCREWS DISENGAGED.
Patient problems: Failure of Implant
MAUDE report 25364722 ↗MalfunctionMay 21, 2026Migration
A POST-OPERATIVE DEVICE-RELATED ISSUE WAS IDENTIFIED IN A PATIENT WHO UNDERWENT SPINAL SURGERY ON (B)(6) 2024, UTILIZING A RESPONSE 5.5/6.0 SCOLIOSIS SYSTEM. THE IMPLANTED DEVICE INCLUDED A LARGE SET SCREW (PART NUMBER: 00-1003-4001). ON (B)(6) 2026, DURING A ROUTINE CLINIC FOLLOW-UP VISIT, THE PATIENT PRESENTED WITH A DISENGAGED SET SCREW. THE EVENT WAS DISCOVERED IN A POST-OPERATIVE CLINICAL SETTING. THERE WAS NO REPORTED DEATH OR PATIENT INJURY ASSOCIATED WITH THIS EVENT; HOWEVER, THE DISENGAGEMENT RESULTED IN THE FAILURE OF THE ORIGINAL SURGICAL CONSTRUCT. AS A RESULT OF THIS DEVICE ISSUE, A REVISION SURGERY HAS BEEN DEEMED NECESSARY, AND SCHEDULING IS PENDING. AT THIS TIME THE DEVICE REMAINS IMPLANTED IN THE PATIENT, AND THEREFORE, NO PRODUCT IS CURRENTLY AVAILABLE FOR RETURN OR EVALUATION.
Patient problems: Failure of Implant
MAUDE report 25241560 ↗MalfunctionMay 15, 2026Fracture
ON (B)(6) 2026, ORTHOPEDIATRICS CORP. RECEIVED A COMPLAINT INVOLVING A 6.0 X 40 MM PEDICLE SCREW (P/N 00-1300-0640, LOT 246588-M) USED DURING A SCOLIOSIS PROCEDURE AT (B)(6) HOSPITAL. THE PEDICLE SCREW SHAFT FRACTURED POST OP. THE SURGEON REPORTED THAT THE TULIP AND A PORTION OF THE SHAFT WERE RETRIEVED; HOWEVER, A PORTION OF THE FRACTURED DEVICE REMAINED IN THE PATIENT. THE EVENT REQUIRED A REVISION PROCEDURE. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED SUCCESSFULLY.
Patient problems: Foreign Body In Patient
MAUDE report 25184466 ↗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 ↗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 ↗MalfunctionApr 28, 2026Fracture
A COMPLAINT WAS REPORTED INVOLVING (6.5 X 45 POLY, PART NUMBER 00-1300-7645; 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 25015640 ↗MalfunctionApr 8, 2026Fracture
1 YEAR POST OP FOLLOW UP PATIENT SHOWED WITH BROKEN SCREW AT LIV.
Patient problems: Failure of Implant
MAUDE report 24815667 ↗MalfunctionMar 24, 2026Migration
PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2025. IN POST OP FILMS BACK IN (B)(6), NO ISSUES SEEN. FOLLOW-UP VISIT WHEN KID SHOWED UP AT CLINIC, AT LEAST 5 SET SCREWS DISENGAGED ON RIGHT SIDE. 6.0.
Patient problems: Failure of Implant
MAUDE report 24681790 ↗MalfunctionMar 24, 2026Migration
PEDICLE SCREW HAD LOOSENED AND WAS NOT IN THE PEDICLE. THIS SCREW WAS REMOVED AND REPLACED WITH A LARGER SCREW AS WELL AS AN ADDITIONAL SCREW AT T8. A NEW EXTENDER WAS ALSO PLACED AND THE MID-C DEVICE WAS RE-IMPLANTED WITH NO ISSUE.
Patient problems: Failure of Implant
MAUDE report 24675628 ↗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 ↗MalfunctionNov 25, 2025Fracture; Fracture
PATIENT CAME BACK TO CLINIC FOR 1 YEAR FOLLOW UP AND SURGEON NOTICED SCREW AT LIV BROKE MID SHAFT.
Patient problems: Failure of Implant
MAUDE report 23648620 ↗MalfunctionNov 25, 2025Fracture; Fracture
BROKEN POLY PEDICLE SCREWS. CAUSED PAIN AND HAD TO REVISE.
Patient problems: Failure of Implant
MAUDE report 23648619 ↗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 ↗
Other Orthopediatrics Corp. products
All Orthopediatrics Corp. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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