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

Model Number CONV DEFIANCE FP

Device Problem Break (1069)

Patient Problem Damage to Ligament(s) (1952)

Event Date 03/12/2019

Event Type  Injury  

Manufacturer Narrative

The reporter did not indicate that the device would be returned for evaluation.If the device is returned, a follow-up report will be submitted upon completion of the evaluation.

Event Description

It was reported that the brace was broken and the patient re-tore her anterior cruciate ligament (acl).No further information was provided.

• Brand Name: DEFIANCE FP
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJO, LLC; 3151 scott st.; vista CA 92081 9663
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 8543938
• MDR Text Key: 142897391
• Report Number: 3012446970-2019-00011
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CONV DEFIANCE FP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention