MAUDE Adverse Event Report: OSSUR CTI CUSTOM PRO SPORT RIGHT KNEE BRACE; ORTHOSIS, LIMB BRACE

Model Number B-117500010

Device Problem Insufficient Information (3190)

Patient Problem Rupture (2208)

Event Date 11/26/2015

Event Type  Injury  

Manufacturer Narrative

This information comes to us in the form of legal action.We are working to receive the product for evaluation.

Event Description

Patient wearing cti knee brace made a jump and came down hard while kitesurfing and ruptured his acl.

• Brand Name: CTI CUSTOM PRO SPORT RIGHT KNEE BRACE
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): OSSUR; blvd hector teran teran 2102; edificio #1, col. de canon del; tijuana, baja california 2102 ; MX 2102
• Manufacturer (Section G): OSSUR; blvd hector teran teran 2102; edificio #1, col. de canon del; tijuana, baja california 2102 ; MX 2102
• Manufacturer Contact: karen montes ; 27051 towne centre drive; foothill ranch, CA 92610 ; 9493823741
• MDR Report Key: 5593938
• MDR Text Key: 43202527
• Report Number: 3008523132-2016-00002
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: B-117500010
• Device Catalogue Number: B-117500010
• Device Lot Number: 0415
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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