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

Catalog Number	ALN-RST-0900
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An implanted align radial stem loosened after five months, requiring revision 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." neither the implant nor images from the case were made available for analysis; however, the patient was described by the rep attending the case as having 'bad bone', with lucency around the radial neck.This likely suggests that the patient was contraindicated for use of the align radial head system.

• Brand Name: SKELETAL DYNAMICS INC.
• Common Device Name: ALIGN RADIAL STEM
• 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: 24747304
• Report Number: 3006742481-2026-00001
• Device Sequence Number: 21161920
• Product Code: KWI
• UDI-Device Identifier: 00841506100166
• UDI-Public: 00841506100166
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K231188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 03/27/2026

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-0900
• Device Lot Number: AN2403044
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2024
• 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: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White