MAUDE Adverse Event Report: TEKNIMED SURGICAL GLUE; CEMENT OBTURATOR

Catalog Number T770014

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Swelling/ Edema (4577)

Event Date 09/05/2019

Event Type  Injury  

Event Description

Clinical adverse event received for swollen left knee event is not serious and is considered mild.Event is possibly related to device and is related to procedure.(left knee) original implant date (b)(6) 2019.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SURGICAL GLUE
• Type of Device: CEMENT OBTURATOR
• Manufacturer (Section D): TEKNIMED
• MDR Report Key: 17530474
• MDR Text Key: 321104318
• Report Number: MW5137393
• Device Sequence Number: 1
• Product Code: LZN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Catalogue Number: T770014
• Device Lot Number: 7718131
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1