MAUDE Adverse Event Report: DJO, LLC FULLFORCE,ACL,STD,CALF,RT,M; JOINT, KNEE, EXTERNAL BRACE

Model Number 11-0258-3

Device Problem Break (1069)

Patient Problem Damage to Ligament(s) (1952)

Event Date 12/05/2018

Event Type  Injury  

Manufacturer Narrative

The device is not available for evaluation.If the device is returned, an investigation will be performed and a follow-up report will be submitted.

Event Description

It was reported that the patient was playing lacrosse when the brace completely broke and caused the patient to re-tear his anterior cruciate ligament (acl).

• Brand Name: FULLFORCE,ACL,STD,CALF,RT,M
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 3151 scott street; vista CA 92081 9663
• Manufacturer (Section G): DJ ORHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana
• Manufacturer Contact: brian becker ; 3151 scott street; vista, CA 92081-9663 ; 7607343126
• MDR Report Key: 8208953
• MDR Text Key: 131807269
• Report Number: 9616086-2018-00026
• 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: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 11-0258-3
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other