Response Spine 5.5/6.0 System 00-1300-0640Recalls & reported problems
Orthopediatrics Corp. · 5.5/6.0 UNIAXIAL 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841132100325), received between Nov 12, 2024 and May 15, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (5 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
- Fracture5
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Failure of Implant1
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗MalfunctionFeb 24, 2025Fracture; Fracture
PATIENT PRESENTED TO CLINIC WITH BROKEN SCREW AT BOTTOM OF CONSTRUCT T12. CONTRUCT IS T2-T12 WITH 6.0 COCR LEFT ROD AND 6.0 TI RT ROD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21447767 ↗MalfunctionDec 11, 2024Fracture; Fracture
PATIENT ARRIVED FOR 1YR POST OP FOLLOW UP AND UPON REVIEWING X RAYS, SURGEON NOTICED DISTAL SCREW WAS BROKEN.
Patient problems: Insufficient Information
MAUDE report 20903272 ↗MalfunctionNov 12, 2024Fracture; Fracture
SCREW INSERTED (B)(6) 2022. FOLLOW UP X-RAY ON (B)(6) 2024, SHOWS A BROKEN SCREW AT THE LIV BELIEVE TO BE 6X40 ASYMPTOMATIC. NO REVISION SCHEDULED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20670030 ↗
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- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 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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