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

Model Number	UEA-MA01-00-01
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Musculoskeletal problem (4535); Insufficient Information (4580)
Date of Event	04/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation ongoing.Devices discarded at hospital.
Event or Problem Description
Osteotomies could not be executed as planned and surgeon had to adapt intra-operatively.Surgeon did revision surgery later on.
Additional Manufacturer Narrative
Devices met specifications and no root cause could be determined.Surgery was complex (monteggia case), which could have played a role.H3: return of device requested but not received.

• Brand Name: SURGICASE
• Common Device Name: PEDIATRIC RADIUS/ULNA OSTEOTOMY GUIDE AND MODEL
• Manufacturer (Section D): MATERIALISE USA, LLC; 44650 helm court; plymouth MI 48170
• Manufacturer (Section G): MATERIALISE USA, LLC; 44650 helm court; plymouth MI 48170
• Manufacturer Contact: jenny jones ; 44650 helm court; plymouth, MI 48170 ; 0032163966
• MDR Report Key: 14572409
• Report Number: 3005718816-2022-00002
• Device Sequence Number: 6169098
• Product Code: PBF
• UDI-Device Identifier: E314UEAMA0100010
• UDI-Public: E314UEAMA0100010
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K163156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2022

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
• Operator of Device: Health Professional
• Device Model Number: UEA-MA01-00-01
• Device Catalogue Number: UEA-MA01-00-01
• Device Lot Number: OO22RICNIJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 9 YR
• Patient Sex: Male