MAUDE Adverse Event Report: BREG, INC. FUSION OA

Model Number 13120

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

Patient Problem Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

No product has been returned for evaluation.The information received does not indicate that the brace malfunctioned or failed to perform its intended function.A historical review of complaint records dating back 3 years revealed no similar reports.

Event Description

Breg received a report of a patient experiencing a hip dislocation while wearing a fusion osteoarthritis knee brace.The patient was skiing when incident occured.The patient is currently wearing a hip brace and conducting physical therapy for his hip.

• Brand Name: FUSION OA
• Type of Device: FUSION OA
• Manufacturer (Section D): BREG, INC.; 2885 loker avenue east; carlsbad CA 92010
• Manufacturer (Section G): BREG, INC.; 2885 loker avenue east; carlsbad CA 92010
• Manufacturer Contact: carol emerson ; 2885 loker avenue east; carlsbad, CA 92010 ; 7607955823
• MDR Report Key: 8488017
• MDR Text Key: 141077670
• Report Number: 2028253-2019-00001
• 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: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2019

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 13120
• Device Catalogue Number: 13120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2019
• Initial Date FDA Received: 04/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization