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

Model Number	O-01-0-101000-0011-010
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unequal Limb Length (4534)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patients ulna was 1cm positive after the correction was finished.
Additional Manufacturer Narrative
On 3/26/2024 surgeon informed materialise that patients ulna was 1cm positive after the correction was finished.However, information was not complete and on april 28th new information was obtained that indicated the occurence of an adverse event with the patient the investigation is on going.
Additional Manufacturer Narrative
During the investigation, it was found that design and planning steps were done according to specifications.Due to the complexity of the surgery several clinical assumptions were made during the pre-operative planning.Surgeon confirmed that the ulnar variance after surgery was neutral, but during follow-up, the patient progressed to an ulna +.The surgeon does not expect longitudinal instability because the radius does not seem to be migrated proximally. .
Event or Problem Description
Patients ulna was 1cm positive after the correction was finished.

• Brand Name: MATERIALISE PERSONALIZED SOLUTION
• Common Device Name: 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; 44650 helm court; plymouth MI 48170
• Manufacturer Contact: jenny jones ; 44650 helm court; plymouth, MI 48170 ; 0032163966
• MDR Report Key: 19376849
• Report Number: 3005718816-2024-00001
• Device Sequence Number: 18029673
• Product Code: PBF
• UDI-Device Identifier: 05420060343261
• UDI-Public: 5420060343261
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 04/28/2024

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-01-0-101000-0011-010
• Device Catalogue Number: O-01-0-101000-0011-010
• Device Lot Number: OO23CARGAF
• 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: 04/28/2024
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2024
• 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: 26 YR
• Patient Sex: Male