MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE PRODUCTS GMBH C-LEG; EXTERNAL ABOVE KNEE PROSTHESIS

Model Number 3C98-3

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Bruise/Contusion (1754); Head Injury (1879)

Event Date 11/13/2016

Event Type  Injury  

Manufacturer Narrative

Device evaluation in progress; supplemental report will be submitted after evaluation of all device components.

Event Description

Pt.Walked from garden in the courtyard and fell over a 10cm step.He stumbled about 1,5m to avoid the fall and collided with his upper body and head a metal garden gate.He hit the ground with his legs and especially with the device.

Manufacturer Narrative

The evaluation of the knee joint showed no relevant error which may have caused the reported fall.No failure detected, device operated within specification.

• Brand Name: C-LEG
• Type of Device: EXTERNAL ABOVE KNEE PROSTHESIS
• Manufacturer (Section D): OTTO BOCK HEALTHCARE PRODUCTS GMBH; brehmstrasse 16; vienna, vienna 1110 ; AU 1110
• MDR Report Key: 6197795
• MDR Text Key: 63052969
• Report Number: 9615892-2016-00017
• Device Sequence Number: 1
• Product Code: ISY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3C98-3
• Device Catalogue Number: 3C98-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Date Manufacturer Received: 01/27/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention