MAUDE Adverse Event Report: OSSUR REHAB CONTOUR AIR LIGHT RIGHT; JOINT, KNEE, EXTERNAL BRACE

Model Number B-220500000

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

Patient Problems Fall (1848); Rupture (2208)

Event Date 04/08/2015

Event Type  Injury  

Event Description

Patient had surgery for quadriceps tendon on his right leg and was wearing a rehab brace.He was walking and stumbled due to weakness in his left leg due to a preexisting nervus femoralis.He tried to avoid falling by using the injured leg wearing the post-operative orthosis.The high loading on the product, outside of what is considered design load, caused the orthosis to bend.Patient suffered a new rupture.Patient then had another surgery for the quadriceps tendon rupture.

• Brand Name: REHAB CONTOUR AIR LIGHT RIGHT
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): OSSUR; foothill ranch CA
• Manufacturer Contact: karen montes ; 27051 towne centre; foothill ranch, CA 92610 ; 9493823741
• MDR Report Key: 4845081
• MDR Text Key: 16174909
• Report Number: 2085446-2015-00001
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/10/2015

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: B-220500000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2015
• Initial Date FDA Received: 06/12/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 100