MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE PRODUCTS GMBH C-BRACE JOINT UNIT; KNEE ORTHOSIS

Model Number 17KO1=R

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Skin Tears (2516); Blister (4537); Insufficient Information (4580)

Event Date 05/18/2022

Event Type  Injury  

Event Description

Product: cbrace issues - the patient feels like he isn't getting good customer service on this product.He feels he wasn't fit properly - this was done over covid and has been cast several times.He had to then have surgery due to injuries caused by the brace, he was sent to physical therapy and they were not trained in the brace properly so they were unable to help him properly.He is very upset with how the fit is and he has continually let kenney know about this and the practitioner.Was told by otto bock that it would cost (b)(6) to recast him for this.The rep has been contacted but keeps directing him back to the orthotic facility-he wants to talk to someone in our clinical/professional services about this.

Manufacturer Narrative

Device is currently not available for evaluation; supplemental report will be submitted after evaluation of all device components is completed.

• Brand Name: C-BRACE JOINT UNIT
• Type of Device: KNEE ORTHOSIS
• Manufacturer (Section D): OTTO BOCK HEALTHCARE PRODUCTS GMBH; brehmstrasse 16; vienna, vienna 1110 ; AU 1110
• Manufacturer Contact: reinhard wolkerstorfer ; brehmstrasse 16; vienna, vienna 1110 ; AU 1110
• MDR Report Key: 15860478
• MDR Text Key: 304280176
• Report Number: 9615892-2022-00017
• 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: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 17KO1=R
• Device Catalogue Number: 17KO1=R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male