MAUDE Adverse Event Report: SKELETAL DYNAMICS INC. SKELETAL DYNAMICS INC.; ALIGN RADIAL HEAD SYSTEM

Catalog Number	ALN-RST-800
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	03/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient's proximal radius fractured around the site of an implanted align radial head construct two years after initial implantation, requiring removal surgery.
Additional Manufacturer Narrative
The instructions for use for the align radial head system states the following: "the align radial head system should not be used if any of the following are present: active or latent infection, insufficient quantity or quality of bone and/or soft tissue, material sensitivity, or patients who are unwilling or incapable of following post-surgical care instructions." "radial head prosthesis cannot be expected to withstand the activity levels and loads of normal healthy bone and joint tissue.Failure of the component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive loads (estimated body weight equivalent of 350 lbs or greater)." "improper selection, placement, positioning, alignment, or fixation of the implanted components may result in unusual stress conditions, which may lead to a subsequent reduction in the service life of the prosthetic components." "malalignment of the components or inaccurate implantation can lead to excessive wear and/or failure of the prosthesis or anatomical structures." "the patient must be cautioned about the use, limitations, and possible adverse effects of this device, including the possibility of device or treatment failure as a result of loosening, stress, excessive activity, or weight bearing or load bearing, and the possibility of nerve or soft tissue damage related to either surgical trauma or the presence of the device." "potential align radial head system construct failures, such as stress fractures of the bones, loosening of the construct and/or fixation, delayed union, union, or incomplete healing, may occur as a result of non-compliance with post-surgery rehabilitation, excessive wrist and forearm activities, or construct overloading." "patient must avoid placing excessive loads on the implant." the stress fracture of the patient's radius likely occured while the patient was load-bearing, however improper implantation is a potential contributing factor.

• Brand Name: SKELETAL DYNAMICS INC.
• Common Device Name: ALIGN RADIAL HEAD SYSTEM
• Manufacturer (Section D): SKELETAL DYNAMICS INC.; 7300 n kendall drive; suite 800; miami FL 33156
• Manufacturer Contact: baron villalta ; 7300 n kendall drive; suite 800; miami, FL 33156 ; 3055967585
• MDR Report Key: 24990560
• Report Number: 3006742481-2026-00003
• Device Sequence Number: 18652888
• Product Code: KWI
• UDI-Device Identifier: 00841506100111
• UDI-Public: 00841506100111
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K172688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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 Catalogue Number: ALN-RST-800
• Device Lot Number: AN2012038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2021
• 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: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White