Skip to content

SKYLINE 286820300Recalls & reported problems

Medos International Sàrl · SKYLINE ANTERIOR CERVICAL PLATE SYSTEM TAP SHAFT 10mm · Class 1

All models of SKYLINE (39)

Data updated Oct 16, 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 10705034215365), received between Oct 20, 2021 and Oct 20, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Device problems

  • Break1

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.

  • MalfunctionOct 20, 2021Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, THE SKY TAP SHAFT WAS USED TO EXPLANT AN NON-J&J CAGE. DURING THE PROCEDURE, THE INSTRUMENT BROKE OFF IN THE CAGE. THE CAGE AND THE FRAGMENT OF THE INSTRUMENT WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) SKY TAP SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12667210 ↗

Other TAP, BONE devices

All TAP, BONE devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page