MAUDE Adverse Event Report: DJO, LLC DONJOY; DEFIANCE DROPLOCK

Model Number CONV DEFIANCE DROPLOCK

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

Patient Problem Fall (1848)

Event Date 01/29/2016

Event Type  Injury  

Manufacturer Narrative

Device not returned.

Event Description

Complaint received that alleges "hinge locked and made him fall, he fell in stairs when one brace locked while he was going down.He woke up in hospital because he lost consciousness after the fall.He stayed couple of days under observation and then he went back home".Questionnaire not received from clinician and/or patient.Device not returned to manufacturer for evaluation.

• Brand Name: DONJOY
• Type of Device: DEFIANCE DROPLOCK
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJO, LLC; 3151 scott street; vista CA 92081 9663
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081 ; 7607313126
• MDR Report Key: 5730060
• MDR Text Key: 47549735
• Report Number: 2020737-2016-00007
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 06/16/2016

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 DROPLOCK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2016
• 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): Hospitalization