MAUDE Adverse Event Report: CORELINK SURGICAL TERRACE ANTERIOR CERVICAL PLATING SYSTEM; 2 LEVEL 44 MM CERVICAL PLATE

Model Number TERRACE 2 LEVEL CERVICAL PLATE

Device Problems Device Issue (2379); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record for the device in question indicated the device complied with all functional and visual final qa acceptance criteria.The plate in question was not returned and could not be examined.It was alleged the surgeon bent the plate ahead of implantation to add additional lordosis.An initial investigation was conducted with similar products and determined that a potential cause of the complaint may be related to the angulation of the screw possibly being outside of what is indicated in the device labeling as it's inserted into the plate.Prior to surgery, the surgeon bent the plate ahead of implantation to add additional lordosis.This is a unique technique the surgeon does for every case to add additional lordosis to the cervical spine.

Event Description

On (b)(6) 2018, an anterior cervical discectomy and fusion (acdf) of the c5 - c7 was performed.The surgeon inserted the top right screw in the cervical plate (2-level plate, 44mm length).The surgeon then inserted the middle left screw which seated without issue.The third screw was positioned by the surgeon in the top right screw pocket and the screw was placed into position.The surgeon continued to screw the plate down when a noise was heard.Surgeon then inserted a screw in the left top contralateral screw hole which caused the right-hand screw to adjust.The surgeon noticed the top right screw head was now through the plate.Surgeon removed both top screws.Surgeon replaced the top right screw with a 4.5 mm self-tapping screw and used 16 mm self drilling variable screws in the rest of the screw holes.Minimal delay in surgery noted.No adverse issues noted with the patient.

• Brand Name: TERRACE ANTERIOR CERVICAL PLATING SYSTEM
• Type of Device: 2 LEVEL 44 MM CERVICAL PLATE
• Manufacturer (Section D): CORELINK SURGICAL; 7911 forsyth blvd.; suite 200; st. louis MO 63105
• Manufacturer (Section G): CORELINK SURGICAL; 1609 manufacturers drive; st. louis MO 63026
• Manufacturer Contact: gary oliveros ; 1609 manufacturers drive; st. louis, MO 63026 ; 8883497808
• MDR Report Key: 7401273
• MDR Text Key: 104803776
• Report Number: 3006494201-2018-00003
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163104
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TERRACE 2 LEVEL CERVICAL PLATE
• Device Catalogue Number: 24200-044
• Device Lot Number: SM74246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR