MAUDE Adverse Event Report: L&K BIOMED CO., LTD LNK LUMBAR INTERBODY FUSION CAGE SYSTEM; INTERVERTEBRAL FUSION DEVICE

Model Number 3810-5010

Device Problem Material Disintegration (1177)

Patient Problem No Code Available (3191)

Event Date 03/08/2017

Event Type  malfunction  

Manufacturer Narrative

The device associated with this report was not returned to the manufacturer for evaluation.According to (b)(4), the broken cage which was removed from the patient was not returnable since the hospital kept it.This complaint is still under investigation.L&k biomed will notify the fda of the results of this investigation once it is completed.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

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 easily through slide equipped with cage holder and finished expanding smoothly.

• Brand Name: LNK LUMBAR INTERBODY FUSION CAGE SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE
• Manufacturer (Section D): L&K BIOMED CO., LTD; #201,16-25 dongbaekjungang-ro; 16 beon gil; yongin-si, giheung-gu KR 44 6-91; KS KR 446-916
• Manufacturer (Section G): L&K BIOMED CO., LTD.; #201, 202 16-25,; dongbaekjungang-ro 16 beon-gil; yongin-si, giheung-gu KR 44 6-91; KS KR 446-916
• Manufacturer Contact: sanghyun kim ; #201, 202 16-25,; dongbaekjungang-ro 16beon-gil; yongin-si, giheung-gu KR 44-6-91 ; KS KR 446-916 ; 2 6717
• MDR Report Key: 6668963
• MDR Text Key: 78568097
• Report Number: 3008285983-2017-00002
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 08806189875871
• UDI-Public: 08806189875871
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3810-5010
• Device Catalogue Number: 3810-5010
• Device Lot Number: 15070105
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other