MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. ARANAX ANTERIOR CERVICAL PLATING SYSTEM

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The complainant reported that a patient that had a previous procedure performed on (b)(6) 2016 required a revision surgery due to the implants impinging the patient's esophagus.The patient entered the emergency room complaining of neck pain, it is unknown if any incidents may have contributed to the patient's onset of neck pain.The emergency room physician requested a spine and gi consult at the hospital, however, a diagnosis was not provided by the hospital to the patient.The patient was referred to a secondary hospital that contained the resources needed to treat the patient.The patient was noted by the emergency room physician to have a history of heavy pain medication use.A dhr review could not be performed because part numbers and lot numbers were not provided by the complainant.If additional details are received, a follow-up report will be submitted.

Event Description

The complainant reported that a patient that had a previous procedure performed on (b)(6) 2016 required a revision surgery due to the implants impinging the patient's esophagus.The complainant was unable to provide the associated part numbers and lot numbers.

• Brand Name: ARANAX ANTERIOR CERVICAL PLATING SYSTEM
• Type of Device: CERVICAL PLATING SYSTEM
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer (Section G): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer Contact: casey ming ; 664 cruiser lane; belgrade, MT 59714 ; 4063880480
• MDR Report Key: 8262907
• MDR Text Key: 133707067
• Report Number: 3005031160-2019-00004
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150834
• 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: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2018
• 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
• Patient Outcome(s): Other