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

Model Number CONV ADJ OA DEFIANCE

Device Problem Material Twisted/Bent (2981)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/05/2019

Event Type  Injury  

Manufacturer Narrative

Occupation: unknown.Device evaluated by mfr: the reporter did not indicate that the device is available for evaluation.If the device becomes available as such, a supplemental report will be submitted with evaluation findings.

Event Description

It was reported that "the frame got bent, he fell while playing golf and broke his femur, accident happened on the 5th and surgery was done on the 6th of january." no further information was provided.

• Brand Name: ADJUSTABLE OA DEFIANCE
• 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 ; 1430 decision street; vista, CA 92081-9663 ; 7607343126
• MDR Report Key: 8411848
• MDR Text Key: 138515230
• Report Number: 3012446970-2019-00006
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CONV ADJ OA DEFIANCE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/14/2019
• Initial Date FDA Received: 03/12/2019
• 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): Required Intervention