TSRH® Spinal System 1556000500Recalls & reported problems
Medtronic Sofamor Danek, Inc. · ROD 1556000500 5.5CHROMALOYPLUS500STRGHT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994789914), received between Jul 20, 2017 and Jun 14, 2018 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (3 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 16, 2026.
Most reported problems
Device problems
- Break3
Patient problems
- No Known Impact Or Consequence To Patient2
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 14, 2018Break; Break
TYPE OF PROCEDURE OR TECHNIQUE USED: SCOLIOSIS CORRECTION LEVELS IMPLANTED: T10 - S1 IT WAS REPORTED THAT POST-OP, THE PRODUCT BROKE. REVISION SURGERY OCCURRED AND THE PRODUCT WAS SUBSTITUTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7603326 ↗InjuryJun 14, 2018Break; Break
TYPE OF PROCEDURE OR TECHNIQUE USED: SCOLIOSIS CORRECTION LEVELS IMPLANTED: T10 - S1 IT WAS REPORTED THAT POST-OP, THE PRODUCT BROKE. REVISION SURGERY OCCURRED AND THE PRODUCT WAS SUBSTITUTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7603268 ↗InjuryJul 20, 2017Break; Break
IT WAS REPORTED THAT, ON (B)(6) 2016, PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SPINAL STENOSIS AND UNDERWENT POSTERIOR INSTRUMENTATION, DECOMPRESSION, ALIF (ANTERIOR LUMBAR INTERBODY FUSION) AT L1-ILIAC. ON AN UNKNOWN DATE, POST-OP, THE ROD BROKE. NEW OPERATION IS BEING PLANNED. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THIS EVENT.
Patient problems: No Code Available
MAUDE report 6728995 ↗
Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page