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LnK Lumbar Interbody Fusion Cage System 3810-5010Recalls & reported problems

L&K Biomed CO. ,Ltd. · L&K Biomed DLIF PEEK Cage 18 x 50 0 10mm 1EA, LLIF PEEK Cage, 0︒, 18x50x10mm · Class 2 · Implant

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 08806189875871), received between Jun 26, 2017 and Jun 26, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Disintegration” (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

  • Material Disintegration1

Patient problems

  • No Code Available1

Recent adverse event reports

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

  • MalfunctionJun 26, 2017Material Disintegration; Material Disintegration

    THE CUSTOMER COMPLAINT WAS RECEIVED FROM (B)(4) ON MAR 14TH, 2017. ACCORDING TO COMPLAINT REPORT, SURGEON PERFORMED LATERAL INTERBODY FUSION AT L2 TO L3, MODEL# 3810-5010 LOT# 15070105,0 DEGREE, 50X18X10MM) ON (B)(6) 2017, PATIENT WAS ABOUT (B)(6) FEMALE NOT FAT AND HAVING GENERAL SHAPE. SINCE THE DISC SPACE WAS TOO NARROW, SURGEON TRIED TO WIDEN USING 8MM DISTRACTOR BUT FAILED, THEN FINALLY WIDENED DISC SPACE USING COPP, CURETTE AND 10MM DISTRACTOR. HE SELECTED 50X10MM CAGE, 0 DEGREE AND FILLED BONE AND BMP, BINDED CAGE AND CAGE HOLDER AND TRIED INSERTION BUT FAILED. HE REQUESTED BIGGER MALLET TO THE CIRCULATOR. IT WAS RECOMMENDED TO USE LATERAL SLIDE BUT HE DENIED AND ATTEMPTED TO INSERT MORE TIME BY MORE MALLETING. WHEN THE CAGE WAS INSERTED ABOUT 20% IT WAS BROKEN, AND HE JUST REMOVED CAGE HOLDER FROM THE SITE. HE ATTEMPTED TO REMOVE BROKEN CAGE SEVERAL TIMES BY USING PITUITARY BUT IT WAS NOT EASY TO REMOVE, HE USED ANOTHER GENERAL INSTRUMENT OF SYNTHES, GLOBUS BUT IT DIDN'T WORK. HE SHARPENED THE CAGE TEETH USING MIDAS DRILL AND BARELY REMOVED IT. RIGHT AFTER REMOVAL THE BROKEN CAGE, HE FINISHED REVISION SURGERY USING SAME SIZE OF GLOBUS DLIF EXPANDABLE CAGE. CAGE WAS INSERTED

    Patient problems: No Code Available

    MAUDE report 6668963 ↗

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Sources and updates

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