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Coral 10-40-0410Recalls & reported problems

Seaspine Orthopedics Corporation · T-20 Driver · Class 1

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 10889981106768), received between May 13, 2021 and May 13, 2021 — 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.

Most reported problems

Device problems

  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 13, 2021Fracture; Fracture

    THE PATIENT UNDERWENT SPINAL SURGERY ON (B)(6) 2020 CONSISTING OF SEASPINE'S CORAL SPINAL SYSTEM. DURING SURGERY, THE 10-40-0410 T-20 DRIVER TIP BROKE WHEN THE SURGEON WAS ADVANCING A PEDICLE SCREW. THE SURGEON DETERMINED THE TIP COULD NOT BE REMOVED FROM THE SCREW HEAD AND COMPLETED THE CASE. THE PATIENT COMPLAINED OF PAIN AND RECEIVED AN MRI. THE SURGEON CONCLUDED THEIR PAIN IS RELATED TO DIABETIC NEUROPATHY AND NOT RELATED TO THE DRIVER TIP WHICH REMAINS IN THE SCREW HEAD. AT THIS TIME, THERE IS NO PLAN FOR REVISION SURGERY, AND THE SURGEON CONTINUES TO MONITOR THE PATIENT'S RECOVERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11820097 ↗

Other SCREWDRIVER devices

All SCREWDRIVER devices →

Sources and updates

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