MAUDE Adverse Event Report: OSSUR CTI OTS RIGHT MEDIUM; ORTHOSIS, LIMB BRACE

Model Number B-238500113

Device Problems Component Missing (2306); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Damage to Ligament(s) (1952); Injury (2348)

Event Date 12/13/2016

Event Type  Injury  

Event Description

Patient was wearing the cti off-the-shelf knee brace while playing hockey.He experienced a hyperextension knee injury.The mri shows a tibial fracture and cartilage damage.No extension stops were found in the brace when it was returned to the clinic of purchase.When the product was last seen at the clinic of purchase, there were 0 degree extension stops in the hinges.

Event Description

Patient was wearing the cti off-the-shelf knee brace while playing hockey.He experienced a hyperextension knee injury.The mri shows a tibial fracture and cartilage damage.No extension stops were found in the brace when it was returned to the clinic of purchase.When the product was last seen at the clinic of purchase, there were 0 degree extension stops in the hinges.

• Brand Name: CTI OTS RIGHT MEDIUM
• 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 ; 9492757557
• MDR Report Key: 6336404
• MDR Text Key: 67602808
• Report Number: 2085446-2017-00003
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: B-238500113
• Device Catalogue Number: B-238500113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2010
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention