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

Model Number	Proximal Ulna Plate, 73mm, Right
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned to manufacturer for review/investigation.Based on the information available, it has been determined that the patient was non-complaint with the post-operative instructions and procedures which likely contributed to the event.The ifu states: "the patient should be informed about the importance of following the post-operative rehabilitation prescribed in order to fully understand the possible limitations in activities of daily living.The patient must be warned that failure to follow postoperative care instructions may cause the implant or treatment to fail." failure to follow post-operative care can cause the treatment to fail.
Event or Problem Description
It was reported that the fracture displaced post-operatively.Implant was removed and replaced.

• Brand Name: SKELETAL DYNAMICS
• Common Device Name: PROXIMAL ULNA PLATE
• Manufacturer (Section D): SKELETAL DYNAMICS; 7300 n. kendall drive; suite 400; miami FL 33156
• MDR Report Key: 11792576
• Report Number: 3006742481-2021-00005
• Device Sequence Number: 11603717
• Product Code: HRS
• UDI-Device Identifier: 00841506105772
• UDI-Public: 00841506105772
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/06/2021

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
• Operator of Device: Health Professional
• Device Model Number: Proximal Ulna Plate, 73mm, Right
• Device Catalogue Number: APL-PUP-3HR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR