MAUDE Adverse Event Report: L&K BIOMED CO.,LTD. CASTLELOC-P; ANTERIOR CERVICAL PLATE SYSTEM

Catalog Number 6712-1737

Device Problems Nonstandard Device (1420); Defective Device (2588); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 10/20/2021

Event Type  malfunction  

Event Description

One of screw hole on cervical plate was not big enough for the screw to go all the way in.The surgeon had to use another plate and pull out 4 screws and put rescue screws.

• Brand Name: CASTLELOC-P
• Type of Device: ANTERIOR CERVICAL PLATE SYSTEM
• Manufacturer (Section D): L&K BIOMED CO.,LTD.; 101,201 202,16-25, dongbaekjun; gang-ro 16 beon-gil giheung-gu; yongin-si, gyeonggi 17015 ; KS 17015
• MDR Report Key: 15459841
• MDR Text Key: 300303945
• Report Number: 3009790163-2022-00001
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/22/2021,11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6712-1737
• Device Lot Number: 20011619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2021
• Distributor Facility Aware Date: 10/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female