Coral 10-17-0001Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10889981027520), received between Dec 19, 2019 and May 31, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Migration” (2 reports).

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2024Migration; Migration

  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 15 MAR 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 19441565 ↗
• MalfunctionMay 31, 2024Migration; Migration

  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 19441517 ↗
• MalfunctionDec 19, 2019Mechanical Problem; Mechanical Problem

  ON (B)(6) 2019, A REVISION SURGERY TOOK PLACE DUE TO THE LOOSENING OF QUANTITY (1) CORAL LOCKING SCREW ASSEMBLY FROM A PRIOR SURGERY (ORIGINAL SURGERY DATE UNKNOWN). THE REVISION WAS COMPLETED SUCCESSFULLY BY REPLACING THE LOCKING SCREW ASSEMBLY. THE PATIENT IS HEALING WELL AS EXPECTED AND THERE ARE NO FURTHER PLANS TO REVISE AT THIS TIME. NO RADIOGRAPHS HAVE BEEN PROVIDED FOR REVIEW, AND THE PRODUCT HAS NOT BEEN RECEIVED BY THE MANUFACTURE FOR ANALYSIS AT THIS TIME.

  Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant

  MAUDE report 9499243 ↗

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 · Terminated
  Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw System).