DYNESYS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-22 for DYNESYS manufactured by Zimmer.

Event Text Entries

[103400106] (b)(6) pt received dynesys scoliosis tethering procedure at (b)(6) hospital in (b)(6). Of licence use. Pt returned to (b)(6); 2 weeks post operatively developed shortness of breath. Discharged from usa to (b)(6). Three weeks post operatively large haemothorax drained. Ct scan showed three screws long and defecting descending arch of aorta. Another screw compression bronchus intermedium causing persistent lung collapse. Revision surgery in (b)(6). All implants infected. Significant lung injury. Screws had been cut to shorten them at initial surgery. Barbed screws had been left rubbing against descending aorta. Pt revised today all implants removed by associated with significant bleeding and persistent lung injury secondary to prominent metalwork and long hard implants.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5075989
• MDR Report Key: 7365162
• Date Received: 2018-03-22
• Date of Report: 2018-03-21
• Date of Event: 2018-02-05
• Date Added to Maude: 2018-03-23
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: DYNESYS
• Generic Name: POSTERIOR METAL / POLYMER SPINAL SYSTEM
• Product Code: NQP
• Date Received: 2018-03-22
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ZIMMER
• Manufacturer Address: US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening	2018-03-22