Response Spine 5.5/6.0 System 00-1300-0740Recalls & reported problems
Orthopediatrics Corp. · 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM 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
- 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 00841132100462), received between Aug 30, 2017 and Aug 30, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Product Quality Problem” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K150600); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- Product Quality Problem1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 30, 2017Product Quality Problem; Product Quality Problem
IT HAS BEEN REPORTED BY THE SALES REPRESENTATIVE THAT DURING REVIEW OF INCOMING INVENTORY, THE SCREW WAS DISCOVERED TO BE ANODIZED THE INCORRECT COLOR. NO PATIENT INVOLVEMENT. NO ADVERSE EVENTS HAVE BEEN REPORTED BECAUSE OF THE MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 6832046 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K150600. One submission often covers many models, so check the product and lot details in each record.
- Z-2742-2020 · Jul 6, 2020 · Open, ClassifiedOrthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in sk
- Z-0597-2018 · Aug 3, 2017 · TerminatedResponse 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
- Z-0622-2016 · Nov 10, 2015 · TerminatedUniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine i
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- 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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