UCR 10-1060Recalls & reported problems
Seaspine Orthopedics Corporation · ROD, 5.5 x 600MM · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889981029449), received between Feb 21, 2020 and Feb 21, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K043232); 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2020Break; Break
MalfunctionFeb 21, 2020Break; Break
ON 01/31/2020 IT WAS REPORTED TO SEASPINE THAT A PATIENT WHO WAS IMPLANTED WITH THE UCR SPINAL SYSTEM EXPERIENCED ROD BREAKAGES, TWO YEARS POST-OPERATIVELY. THE PATIENT HAD IMPLANTS PLACED FROM T11-L4, IN (B)(6) 2017. IN (B)(6) 2019, IT WAS DISCOVERED VIA X-RAY THAT THE BOTH RODS HAD FRACTURED AT L2. AT THE TIME OF THIS REPORT, IT WAS INDICATED THAT THE PATIENT HAD NOT UNDERGONE REVISION SURGERY. THE PATIENT IS BEING MONITORED BY THEIR DOCTOR AS THEY ARE ON MEDICATION THAT COULD CAUSE INTERFERENCE WITH AN ADDITIONAL SURGICAL PROCEDURE. NO ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9741349 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K043232. One submission often covers many models, so check the product and lot details in each record.
- Z-1841-2014 · May 21, 2014 · TerminatedIntegra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying reduction heights provided with t
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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