MAUDE Adverse Event Report: TYRX, INC. AIGIS; MESH, SURGICAL, POLYMERIC

Model Number TYRX-AAE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 09/23/2016

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device lot numbers.The mean age of the patients was sixty-four (64) years of age and 63.7% were male.Since no device id was provided, it is unknown if this event has been previously reported.Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ¿complication rates, lengths of stay, and readmission rates in ¿awake¿ and ¿asleep¿ deep brain simulation.¿ journal of neurosurgery.Published online september 23, 2016; doi: 10.3171/2016.6.Jns152946.

Event Description

A journal article was reviewed which contained information regarding implantable absorbable antibacterial envelopes.Multiple patients were noted in the article; however, a one to one correlation could not be made with device lot numbers.There were three patients who experienced postoperative infections.The systems and envelopes were explanted.Further follow up did not yet yield any additional information.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the senior author which indicated the antibacterial envelope was not used in any of the patients mentioned in the article.There is no information in this article to suggest that the use of the envelope contributed to any of these infections.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: AIGIS
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): TYRX, INC.; 1 deer park dr.; suites g, e; monmouth jct NJ 08852
• Manufacturer (Section G): TYRX, INC.; 1 deer park dr.; suites g, e; monmouth jct NJ 08852
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6164077
• MDR Text Key: 62121060
• Report Number: 3005619263-2016-00053
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: TYRX-AAE
• Device Catalogue Number: TYRX-AAE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 64 YR