MAUDE Adverse Event Report: SKELETAL DYNAMICS INC. SKELETAL DYNAMICS INC.; PROXIMAL ULNA PLATE

Model Number	Proximal Ulna Plate, 73mm, Left
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A proximal ulna plate fractured about 6 months post-implantation.
Additional Manufacturer Narrative
Complaint part is not available for return.Representative reported that a revision has not yet been performed.Reports from the patient confirm that excessive load bearing events occurred.The patient began feeling pain following those events.The fracture does not appear to have healed.However, the patient did not suffer any significant injury as a result of this failure.

• Brand Name: SKELETAL DYNAMICS INC.
• Common Device Name: PROXIMAL ULNA PLATE
• Manufacturer (Section D): SKELETAL DYNAMICS INC.; 7300 n kendall drive; miami FL 33156
• Manufacturer (Section G): SKELETAL DYNAMICS INC.; 7300 n kendall drive; miami FL 33156
• Manufacturer Contact: alejandro ros ; 7300 n kendall drive; miami, FL 33156 ; 3055967585
• MDR Report Key: 16876498
• Report Number: 3006742481-2023-00008
• Device Sequence Number: 7460918
• Product Code: HRS
• UDI-Device Identifier: 00841506105789
• UDI-Public: 00841506105789
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: Proximal Ulna Plate, 73mm, Left
• Device Catalogue Number: APL-PUP-9HL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Sex: Male