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

Catalog Number	6712-1737
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
One of screw holes on the 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
• Common Device Name: ANTERIOR CERVICAL PLATE SYSTEM
• Manufacturer (Section D): L&K BIOMED; [#101, #201,#202, 16-25 dong-; baekjungang-ro 16 beon gil; yongin-si, giheung-gu 17015 ; KS 17015
• Manufacturer (Section G): LNK BIOMED; #101,#201,#202 16-25, dong-; baekjungang-ro 16beon-gil; yongin-si, giheung-gu 17015 ; KS 17015
• Manufacturer Contact: jinwoo cho ; #101, #201,# 202 16-25, dong-; baekjungang-ro 16beon-gil; yongin-si, giheung-gu 17015 ; KS 17015
• MDR Report Key: 12887892
• Report Number: 3008285983-2021-00001
• Device Sequence Number: 14491253
• Product Code: KWQ
• UDI-Device Identifier: 08806189893486
• UDI-Public: 8806189893486
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female