MAUDE Adverse Event Report: OSSUR MEXICO CTI; KNEE BRACE

Model Number B-116500010

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

Patient Problem Injury (2348)

Event Date 09/06/2019

Event Type  Injury  

Manufacturer Narrative

The user had a previous knee injury and no failure or malfunction could be identified on the device.Based on this, it is unlikely that the brace caused or contributed to the event.The user sustained a torn acl, injured chondral, knee effusion, and a baker's cyst from playing football, an extreme sport.Currently the user is undergoing physical therapy to regain rom of the right knee, however, the injury requires surgical intervention.The surgery has yet to be scheduled.The doctor anticipates a full recovery after 6 months of rehabilitation post surgery.No further action is warranted at this time.

Event Description

Patient was reinjured in a football game and suffered acl and grade 2 mcl tear.

• Brand Name: CTI
• Type of Device: KNEE BRACE
• Manufacturer (Section D): OSSUR MEXICO; blvd. hector teran teran 2102; build.#1 col. canon del padre; tijuana, 22206 ; MX 22206
• Manufacturer Contact: katla axelsdottir ; grjothals 1-5; reykjavik 110 ; IC 110
• MDR Report Key: 9189957
• MDR Text Key: 166133100
• Report Number: 3008523132-2019-00002
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: B-116500010
• Device Catalogue Number: B-116500010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other