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SKYLINE 186801028Recalls & reported problems

Medos International Sàrl · SKYLINE ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 28mm · Class 2 · Implant

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 10705034133621), received between Aug 29, 2017 and Aug 29, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K052552, K171439); 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 16, 2026.

Most reported problems

Device problems

  • Mechanical Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionAug 29, 2017Mechanical Problem; Mechanical Problem

    SALES REP CALLED TO REPORT THE CAM DID NOT TORQUE. CONTINUED TO SPIN. SURGEON LEFT PLATE IMPLANTED. PER COMPLAINT FORM: ALL SCREWS WERE PLACED WHEN LOCKING CAM DID NOT TORQUE. SURGEON ROTATED IT OVER SCREW AND LEFT THE IMPLANT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6827983 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052552, K171439. One submission often covers many models, so check the product and lot details in each record.

  • Z-0627-2017 · Oct 12, 2016 · Terminated
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm Item Code: 186852026 The SKYLINE Anterior Cervical Plate System is indicated for stabili
  • Z-0625-2017 · Oct 12, 2016 · Terminated
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186852018 The SKYLINE Anterior Cervical Plate System is indicated for stabi
  • Z-0629-2017 · Oct 12, 2016 · Terminated
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm Item Code: 186862018 The SKYLINE Anterior Cervical Plate System is indicated for stabi
  • Z-0630-2017 · Oct 12, 2016 · Terminated
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 18mm Item Code: 186864018 The SKYLINE Anterior Cervical Plate System is indicated for stabil
  • Z-0628-2017 · Oct 12, 2016 · Terminated
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm Item Code: 186854018 The SKYLINE Anterior Cervical Plate System is indicated for stabilizat
  • Z-0626-2017 · Oct 12, 2016 · Terminated
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 20mm Item Code: 186852020 The SKYLINE Anterior Cervical Plate System is indicated for stabiliz
  • Z-0624-2017 · Oct 12, 2016 · Terminated
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186850018 The SKYLINE Anterior Cervical Plate System is indicated for stabi

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Sources and updates

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