Coral 10-18-0045Recalls & reported problems
Seaspine Orthopedics Corporation · Straight Rod 5.5 x 45 · Class 2 · Implant
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 10889981028862), received between Mar 27, 2017 and Mar 27, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 other recall cover devices cleared under the same FDA submission (K041592); 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
- Break1
- Mechanical Problem1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 27, 2017Break; Mechanical Problem; Break; Mechanical Problem
((B)(4) 3012120772 2017 00003 & (B)(4) 3012120772 2017 00004 RELATE TO ROD AND SCREW FOR SAME PATIENT). PRIOR TO 2014, THE INITIAL POSTERIOR FIXATION SURGERY WAS PERFORMED AT LEVELS L2 - L4. IN 2014, REVISION SURGERY OCCURRED TO EXTEND CONSTRUCT FROM LEVEL T5 TO S1. ON (B)(6) 2015 THE INDEX SURGERY FOR LEVEL S2 (SCREW AND ROD RELATED TO THIS EVENT), INVOLVED RE-INSTRUMENTING/EXTENDING CONSTRUCT FROM T2 THROUGH S2 DUE TO PSEUDARTHROSIS AT L4 - S1. ON (B)(6) 2017 REVISION SURGERY OCCURRED FOR FAILED ILIAC SCREW AT S2 AND ROD FRACTURE AT L5-S1. CONSTRUCT FAILURE WAS SYMPTOMATIC DUE TO INCREASED PAIN AND DEFORMITY. ADDITIONALLY THE PATIENT HAD CONTINUED PSEUDOARTHROSIS. THE REVISION SURGERY REPLACED THE FAILED 8.5 X 70MM RIGHT ILLIAC SCREW (S2), IN WHICH THE SHANK HEAD HAD FRACTURED FROM THE BONE SCREW SHANK. ALSO, THE LEFT 45MM ROD FRACTURE WAS REPLACED ANOTHER 45MM ROD AND BRIDGED WITH A "U" SHAPED ROD-TO-ROD CONNECTOR AND ALSO INVOLVED AUTOGRAFT AND BIOLOGICS.
Patient problems: Failure of Implant
MAUDE report 6435756 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K041592. One submission often covers many models, so check the product and lot details in each record.
- Z-0183-06 · Oct 4, 2005 · TerminatedTorque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw System).
Other Orthosis, spondylolisthesis spinal fixation devices
- CD HORIZON® Spinal System 7540020Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation257 reports
- MANTIS Redux 48289999Stryker Corporation · Orthosis, spondylolisthesis spinal fixation76 reports
- EXPEDIUM TOP NOTCH 179771555Depuy Spine, LLC · Orthosis, spondylolisthesis spinal fixation41 reports
- EXPEDIUM 179712650Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation31 reports
- EXPEDIUM VERSE 199721530Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
- CD HORIZON® Spinal System 7576545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation26 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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