MAUDE Adverse Event Report: ASTURA MEDICAL ASTURA IMPLANTS; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 07/06/2020

Event Type  malfunction  

Event Description

Patient brought back to surgery from previous admission due to locking caps on the construction becoming loose.Type of surgery: spinal fusion.Type of equipment: implants.Elderly male had elective t6-l2 instrumentation revision and exploration of fusion.It was found in surgery that spine caps l1/l2 bilaterally and t10 on left were disconnected.Patient has stage iv metastatic melanoma with metastasis to the spine and is s/p (status post) radiation.

• Brand Name: ASTURA IMPLANTS
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ASTURA MEDICAL; 4949 w royal ln; irving TX 75063
• MDR Report Key: 12091976
• MDR Text Key: 259183920
• Report Number: 12091976
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 06/18/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA