MAUDE Adverse Event Report: DJO, LLC PROCARE NEXTEP CONTOUR WALKER,LARGE; ORTHOSIS, LIMB BRACE

Model Number 79-95067

Device Problem Device Slipped (1584)

Patient Problems Fall (1848); Spinal Column Injury (2081)

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.

Event Description

It was reported that the patient "was at the site where his home was being built.He and his wife on the back covered deck.As he was taking a step, the felt bottom of the boot suddenly slipped forward on the wooden deck.As his suddenly slid forward, he fell backwards off the deck and fell approximately 15 feet to the ground.Plaintiff was taken by ambulance to (b)(6) hospital in (b)(6), where he received extensive medical treatment, including several nights stay." [sic] patient reports that "he was caused to suffer compression fractures to his spine, internal injuries, pain and suffering, emotional distress, and he was caused to be permanently injured." no further information is available at this time.

• Brand Name: PROCARE NEXTEP CONTOUR WALKER,LARGE
• Type of Device: ORTHOSIS, LIMB BRACE
• 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, b.c. 22244 ; MX 22244
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 8899863
• MDR Text Key: 155650108
• Report Number: 9616086-2019-00056
• Device Sequence Number: 1
• Product Code: IQI
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 79-95067
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2019
• 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): Hospitalization; Disability