MAUDE Adverse Event Report: CORELINK SURGICAL LLC M3 STAND-ALONE ANTERIOR LUMBAR SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number LK300-1000

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 01/28/2019

Event Type  malfunction  

Event Description

When viewing the one month post operative images, it appeared that the plate had disengaged from the interbody cage and was sitting in an anterior position to the cage.The fixation screws and interbody device have remained in the proper location.Follow up attempts have been made by corelink to obtain additional information from the surgeon and distributor, but no additional information has been received.

• Brand Name: M3 STAND-ALONE ANTERIOR LUMBAR SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): CORELINK SURGICAL LLC; 2072 fenton logistics blvd.; fenton MO 63026
• Manufacturer (Section G): CORELINK SURGICAL LLC; 2072 fenton logistics blvd; fenton MO 63026
• Manufacturer Contact: allison schmidt ; 2072 fenton logistics blvd; fenton, MO 63026 ; 8883497808
• MDR Report Key: 8360299
• MDR Text Key: 137377075
• Report Number: 3006494201-2019-00002
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LK300-1000
• Device Catalogue Number: LK300-1000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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