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

Model Number 3C98-3

Device Problems Insufficient Information (3190); Device Handling Problem (3265)

Patient Problems Fall (1848); Fracture, Arm (2351)

Event Date 07/10/2018

Event Type  Injury  

Manufacturer Narrative

Device is currently not available for evaluation (not returned from the customer yet); supplemental report will be submitted after evaluation of all device components is completed.

Event Description

Patient fell - fall in a store following unexpected unlocking of the knee (no obstacle, no load port, no slipping), resulting in a fracture of the forearm and double wrist fracture (arm brachial plexus).(b)(6) informed us that the patient did not come yesterday and that he had to see the surgeon for his fractures today or tomorrow.The patient was hospitalized for a broken forearm and double wrist fracture (brachial plexus arm).

Manufacturer Narrative

Evaluation and investigation of the knee joint showed no relevant error which may have caused or contributed to the occurred event.

• Brand Name: C-LEG
• Type of Device: EXTERNAL ABOVE KNEE PROSTHESIS
• Manufacturer (Section D): OTTO BOCK HEALTHCARE PRODUCTS GMBH; brehmstrasse 16; vienna, 1110 ; AU 1110
• MDR Report Key: 7693675
• MDR Text Key: 114156137
• Report Number: 9615892-2018-00020
• 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,health profession
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• 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: 09/11/2018
• Date Manufacturer Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 81