MAUDE Adverse Event Report: DJO, LLC DEFIANCE FP PLUS; JOINT, KNEE, EXTERNAL BRACE

Model Number CONV DEFIANCE FP PL

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 08/28/2018

Event Type  Injury  

Event Description

It was reported that, after receiving clearance from his doctor and while playing in his first soccer game after 11 months of rehab, the patient collided with another player and re-tore his anterior cruciate ligament (acl).

Manufacturer Narrative

The brace was returned to the manufacturer for evaluation.Brace is in good condition and functional.The brace is built within specifications.No issues were found.

• Brand Name: DEFIANCE FP PLUS
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 8277879
• MDR Text Key: 134099972
• Report Number: 3012446970-2019-00003
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CONV DEFIANCE FP PL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Initial Date Manufacturer Received: 01/11/2019
• Initial Date FDA Received: 01/25/2019
• Supplement Dates Manufacturer Received: 01/11/2019
• Supplement Dates FDA Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention