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

Model Number CONV DEFIANCE DROPLOCK

Device Problem Detachment Of Device Component (1104)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 07/02/2015

Event Type  Injury  

Event Description

Per 21 cfr 803, an mdr reportable event, complaint received that alleges "report that she was walking and the droplock hinge dis-engaged and she fell to the floor and broke her nose and glasses." product not returned for evaluation or review.No additional information received from patient or clinician regarding additional details of incident.No indication of device cause or contribution to the event.

Manufacturer Narrative

Mfr report number needs to be update to (b)(4) as (b)(4) includes the incorrect manufacturer registration number.Device manufactured by (b)(4).Registration number (b)(4).Not returned.

• Brand Name: DONJOY
• Type of Device: DEFIANCE DROPLOCK KNEE BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision st.; vista CA 92081
• Manufacturer (Section G): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081 ; 7607313126
• MDR Report Key: 5001025
• MDR Text Key: 22893363
• Report Number: 9616086-2015-00021
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Unknown
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• 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
• Device Catalogue Number: CONV DEFIANCE DROPLOCK
• Device Lot Number: 20140926153 R00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention