MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION MICROMYST APPLICATOR; SYRINGE, PISTON

Model Number 205000DS

Device Problems Use of Device Problem (1670); Failure to Advance (2524)

Patient Problem Insufficient Information (4580)

Event Date 05/28/2021

Event Type  malfunction  

Event Description

Duraseal system - exact spine sealant system polymer kit / and micromyst applicator were unable to express the duraseal polymer product.The syringe plungers were unable to be advanced.Fda safety report id # (b)(4).

• Brand Name: MICROMYST APPLICATOR
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; princeton NJ 08540
• MDR Report Key: 11929873
• MDR Text Key: 254377338
• Report Number: MW5101682
• Device Sequence Number: 2
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/01/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 205000DS
• Device Catalogue Number: 205000DS
• Device Lot Number: 2021010572
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR