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

Catalog Number	ALN-RHI-260
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Metal Related Pathology (4530); Implant Pain (4561)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An implanted align radial head was loose, requiring revision surgery.
Additional Manufacturer Narrative
The instructions for use for the align radial head system states the following: "the lock screw packaged with the radial head must be installed and fully tightened to fix the radial head to the radial stem.The radial head prosthesis is designed to become a monoblock following fixation of the lock screw.If the lock screw is not attached and/or fully secured, the radial head may loosen and/or disconnect from the radial stem, causing soft tissue irritation and/or device failure." " 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." "seek medical help immediately if implant malfunctions." although no images from the case were provided, this event is consistent with known risks associated with improper implantation as described in the instructions for use.Metallosis is a known potential outcome associated with implant loosening that can be avoided by addressing a malfunction as soon as it occurs.

• 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: 24967882
• Report Number: 3006742481-2026-00002
• Device Sequence Number: 16076466
• Product Code: KWI
• UDI-Device Identifier: 00841506100050
• UDI-Public: 00841506100050
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K172688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/22/2026

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-260
• Device Lot Number: AN1909005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2020
• 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: 41 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White