MAUDE Adverse Event Report: MATERIALISE NV SURGICASE; HUMERUS OSTEOTOMY GUIDE AND MODEL

Model Number	O-01-0-105000-0011-010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient experienced an infection post-operatively, requiring oral antibiotics.
Additional Manufacturer Narrative
No root cause found for the infection.Devices met specifications.Device return would not lead to additional information.

• Brand Name: SURGICASE
• Common Device Name: HUMERUS OSTEOTOMY GUIDE AND MODEL
• Manufacturer (Section D): MATERIALISE NV; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• Manufacturer (Section G): MATERIALISE NV; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• Manufacturer Contact: jenny jones ; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• MDR Report Key: 15011000
• Report Number: 3003998208-2022-00015
• Device Sequence Number: 16773543
• Product Code: PBF
• UDI-Device Identifier: E314O01010500000110100
• UDI-Public: E314O01010500000110100
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K112389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/08/2022

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: O-01-0-105000-0011-010
• Device Catalogue Number: O-01-0-105000-0011-010
• Device Lot Number: OO21ZUFDUT
• 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: 07/08/2022
• Initial Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• 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: 12 YR
• Patient Sex: Male