MAUDE Adverse Event Report: KLS MARTIN GROUP KLS PLATES

Lot Number 33209098

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Code Available (3191)

Event Date 01/15/2018

Event Type  Injury  

Event Description

Patient with closed fracture of rib had a left thoracoscopy video assisted vats, plating 6th and 7th rib on (b)(6) 2017.This was part of a requested trial of kls plates by dr.Due to non union, the patient returned to the operating room on (b)(6) 2018 for left thoracoscopy video assisted vats, rib plate hardware removal x 2 ribs, rib plating x 2 ribs.

• Brand Name: KLS PLATES
• Type of Device: PLATES
• Manufacturer (Section D): KLS MARTIN GROUP
• MDR Report Key: 7321342
• MDR Text Key: 101880386
• Report Number: 7321342
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 33209098
• Other Device ID Number: REF 24-015-22-71
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2018
• Distributor Facility Aware Date: 02/13/2018
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 77 YR