MAUDE Adverse Event Report: WARSAW ORTHOPEDICS METRX SYSTEM; LIGHT, SURGICAL, CARRIER

Catalog Number 9560802

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 03/21/2017

Event Type  Injury  

Manufacturer Narrative

The product is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.

Event Description

It was reported that patient underwent minimally invasive spine decompression surgery.Intra-op, light burned the patient's back.While in use, light was laying on patients back with rubber safety piece over where it attaches to light source.After case 'pa' stated that the light burned the patients back.

• Brand Name: METRX SYSTEM
• Type of Device: LIGHT, SURGICAL, CARRIER
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6492549
• MDR Text Key: 72783474
• Report Number: 1030489-2017-00813
• Device Sequence Number: 1
• Product Code: FSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9560802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other