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L’DISQ® PC01Recalls & reported problems

CG MedTech Co.,Ltd. · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08800015911818), received between Apr 9, 2018 and Nov 20, 2019 — classified as 2 injuries.

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

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

  • Fracture2

Patient problems

  • Neck Pain1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 20, 2019Fracture; Fracture

    PROCEDURE WAS PERFORMED ON NOV 04, 2019 TO TREAT THE HERNIATED DISK BY INSERTING THE DEVICE (L'DISQ C) BETWEEN C5 AND C6 VERTEBRAE. AFTER THE DISC COMPRESSION PROCEDURE WAS PERFORMED TO ELIMINATE THE TARGETED ISSUE OF THE DISC, THE SURGEON REMOVED THE INSERTED DEVICE (L'DISQ C) FROM THE PATIENT'S BODY TO FINISH THE PROCEDURE. THEN IT WAS CONFIRMED THAT THE PART OF END TIP OF THE DEVICE REMAINED IN THE PATIENT'S BODY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9345860 ↗
  • InjuryApr 9, 2018Fracture; Fracture

    THIS EVENT OCCURRED IN (B)(6). THE PATIENT HAD DISC DISEASE BETWEEN C5 AND C6 VERTEBRAE. THE PATIENT UNDERWENT DISC DECOMPRESSION PROCEDURE TO ELIMINATE HERNIATED TISSUES OF THE DISC ON (B)(6) 2018. TIP OF THE DEVICE (L'DISQ C) WAS BROKEN OFF IN PROCESS OF THE PROCEDURE. ON LAST WEEK OF (B)(6), BROKEN TIP WAS REMOVED FROM DISC THROUGH SURGERY.

    Patient problems: Neck Pain

    MAUDE report 7410425 ↗

Other ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES devices

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Sources and updates

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