MAUDE Adverse Event Report: DJO LLC. DONJOY TITANIUM, A22; JOINT, KNEE, EXTERNAL BRACE

Model Number CONV TITANIUM

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 06/26/2020

Event Type  Injury  

Manufacturer Narrative

Unknown.

Event Description

Per 21 cfr part 803, cc-00303612 has been assessed as an mdr-reportable event.It was reported that the patient "retore their acl while wearing the brace." no further information is currently available.The device has not been returned for evaluation.There is no further information available at this time.No further information is currently available.

• Brand Name: DONJOY TITANIUM, A22
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO LLC.; 1430 decision street; vista CA 92081
• Manufacturer (Section G): DJO LLC; 3151 scott street; vista CA 92081
• Manufacturer Contact: christine bonczyk ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 10575071
• MDR Text Key: 208184646
• Report Number: 3012446970-2020-00025
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CONV TITANIUM
• Date Manufacturer Received: 07/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other