MAUDE Adverse Event Report: OSSUR MEXICO CTI CUSTOM; KNEE BRACE

Model Number B-118600010

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

Patient Problem Unspecified Tissue Injury (4559)

Event Date 04/10/2021

Event Type  Injury  

Manufacturer Narrative

The patient was playing touch football when the event occurred.

Event Description

The patient hyperextended the knee while wearing the brace causing the acl to re-tear.Acl reconstruction surgery was performed in (b)(6) 2021.

• Brand Name: CTI CUSTOM
• Type of Device: KNEE BRACE
• Manufacturer (Section D): OSSUR MEXICO; blvd. hector teran teran 2102; build.#1 col. canon del padre; tijuana, baja california 22206 ; MX 22206
• Manufacturer Contact: katla axelsdottir ; grjothals 1-5; reykjavik, 110 ; IC 110
• MDR Report Key: 12420134
• MDR Text Key: 269740291
• Report Number: 3008523132-2021-00001
• 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: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: B-118600010
• Date Manufacturer Received: 06/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention