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

Model Number 6712-1741

Device Problem Material Disintegration (1177)

Patient Problem Failure of Implant (1924)

Event Date 02/14/2017

Event Type  malfunction  

Manufacturer Narrative

The device associated with this report was not returned to the manufacturer for evaluation.According to aegis spine, the pathology department of the hospital did not provide the devices and they are under investigation of the devices.Additional request were made to the aegis spine for device lot number and its return but no additional information was obtained.This complaint is still under investigation.L&k biomed will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

On (b)(6) 2017, med3 associates inc.(us distributor of aegis spine) reported the complaint to aegis spine (us agency of l&k biomed), and aegis spine reported it to l&k biomed on (b)(6) 2017.According to med3 associates inc., dr.(b)(6) performed acdf surgery on (b)(6), 2016 using castleloc-p model# is 6712-1741 (2 level 41mm) and lot# is unknown, and upon investigation it was discovered that the cam at one of the c7 screws had broken off at some point since the surgery in (b)(6).The patient was about 7 weeks post-op and denied falling or any motor vehicle accident but has been non-compliant with her neck brace.Dr.(b)(6) had retrieved the free-floating cam from the patient and took out that 16mm screw.He did not put in a rescue screw because there was no locking mechanism.Med3 associates inc.Says that the patient does not have great lordosis and is rather straight and almost kyphotic according to patient x-ray picture provided by hospital, and it was said it is difficult to assess but i believe there may also have been a narrow disk height of c7 - t1 along with not wearing her neck brace which may have contributed to the forces that were generated to cause the screw to back out and subsequently push the camlock off the plate.

• Brand Name: CASTLELOC-P ANTERIOR CERVICAL PLATE SYSTEM
• Type of Device: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): L&K BIOMED CO., LTD; 16-25, dongbaekjungang-ro 16 b; giheung-gu; yongin-si, gyeonggi-province 17015 ; KS 17015
• Manufacturer (Section G): L&K BIOMED CO., LTD.; 16-25, dongbaekjungang-ro; giheung-gu; yongin-si, gyeonggi-province 17015 ; KS 17015
• Manufacturer Contact: shin hyemi ; 16-25, dongbaekjungang-ro; giheung-gu; yongin-si, gyeonggi-province 17015 ; KS 17015 ; 82 2
• MDR Report Key: 6668960
• MDR Text Key: 78585500
• Report Number: 3008285983-2017-00001
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 08806189893509
• UDI-Public: 08806189893509
• Combination Product (y/n): N
• PMA/PMN Number: K143271
• 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: 03/09/2017

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6712-1741
• Device Lot Number: UNDER INVESTIGATION
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability