MAUDE Adverse Event Report: DJO, LLC; COOL, X-ACT ROM, POST-OP

Model Number 11-2151-9

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2017

Event Type  Injury  

Event Description

Complaint received that alleges "that brace was locked at zero, he heard a pop when he took a step, his knee bent and he fell.Stated that the brace was still showing that it was locked at zero degrees.Patient went to see his doctor on (b)(6) and again on (b)(6) 2017, the doctor said that he knee appears to be fine.Bottom part of brace frame was bent, the patient used a tool to bend it back into position.".Questionnaire not received from customer or clinician.Device not received manufacturer at this time.

• Type of Device: COOL, X-ACT ROM, POST-OP
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, 22244 ; MX 22244
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081-9663 ; 7607343126
• MDR Report Key: 7068425
• MDR Text Key: 93247516
• Report Number: 9616086-2017-00021
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2017

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: 11-2151-9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/29/2017
• 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