MAUDE Adverse Event Report: Skeletal Dynamics Inc. Skeletal Dynamics; ALIGN Radial Head System

Catalog Number	ALN-RHI-XXX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An implanted align radial head loosened after seven years, requiring revision surgery.
Additional Manufacturer Narrative
The instructions for use for the align radial head system includes the following warnings and precautions: "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." "the patient should be informed about the importance of following the post-surgical rehabilitation to fully understand the limitations in normal activities of daily living.The patient must be warned that failure to follow post-surgical care instructions may cause the prosthesis or treatment to fail." "patient must avoid placing excessive loads on the implant." although the patient did not recall a specific traumatic event which likely resulted in this failure, they did claim that they "felt something happened" three months earlier.Improper implantation was not able to be established after reviewing images of the failure, consistent with the patient's seven years of successful implantation.The patient may have been over-exerting their elbow joint during daily living activities or experienced an event which they did not link to this failure.

• Brand Name: Skeletal Dynamics
• 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 ; +1(305)596-7585
• MDR Report Key: 50105964
• Report Number: 3006742481-2026-00013
• Device Sequence Number: 10076570
• Product Code: KWI
• UDI-Device Identifier: 00841506100050
• UDI-Public: 00841506100050
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K172688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/24/2026

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 Catalogue Number: ALN-RHI-XXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 200 LB
• Patient Race: White