Coral 18-12-6550Recalls & reported problems
Seaspine Orthopedics Corporation · Solid Polyaxial Screw, 6.50mm x 50mm · Class 2
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 10889981016012), received between May 31, 2024 and May 31, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
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
- Fracture1
Patient problems
- Implant Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 31, 2024Fracture; Fracture
ON (B)(6) 2023 A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S CORAL AND MALIBU POSTERIOR FIXATION SYSTEMS. AN MRI WAS PERFORMED AN UNKNOWN TIME LATER AFTER THE PATIENT REPORTED PAIN. THE 18-12-6550 SOLID POLYAXIAL SCREW, 6.50MM X 50MM WAS OBSERVED TO HAVE FRACTURED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 AND TWO 10-17-0001 LOCKING SCREW ASSEMBLIES WERE OBSERVED TO BE LOOSE AS WELL. IT WAS NOT POSSIBLE TO REMOVE THE ENTIRE BROKEN SCREW, SO THE SURGEON LEFT THE EMBEDDED PIECE IN THE PATIENT AND INSERTED A NEW SCREW AT A DIFFERENT TRAJECTORY. THE SCREW, SCREW ASSEMBLIES, AND A 12-1040 PRECONTOURED ROD, 5.5 X 40MM WERE EXPLANTED.
Patient problems: Implant Pain
MAUDE report 19441571 ↗
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- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
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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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