MAUDE Adverse Event Report: MATERIALISE USA, LLC SURGICASE; RADIUS/ULNA OSTEOTOMY, PEDIATRIC

Model Number UEA-MA01-00-01

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

Patient Problem Loss of Range of Motion (2032)

Event Date 02/26/2021

Event Type  Injury  

Manufacturer Narrative

Investigation ongoing.

Event Description

Expected outcome of radius and ulna correction not met and most likely revision surgery will be needed.

Manufacturer Narrative

Devices met specifications and no root cause could be determined.Patient had pre-existing medical condition that could have played a role.H3: return of device requested but no reply received.

• Brand Name: SURGICASE
• Type of Device: RADIUS/ULNA OSTEOTOMY, PEDIATRIC
• Manufacturer (Section D): MATERIALISE USA, LLC; 44650 helm court; plymouth MI 48170
• MDR Report Key: 11670071
• MDR Text Key: 246200390
• Report Number: 3005718816-2021-00001
• Device Sequence Number: 1
• Product Code: PBF
• UDI-Device Identifier: E314UEAMA0100010
• UDI-Public: E314UEAMA0100010
• Combination Product (y/n): N
• PMA/PMN Number: K163156
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UEA-MA01-00-01
• Device Catalogue Number: UEA-MA01-00-01
• Device Lot Number: OO21ENIOZA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2021
• Supplement Dates Manufacturer Received: 07/22/2021
• Supplement Dates FDA Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 12 YR