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

Catalog Number	ALN-RHI-260
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Metal Related Pathology (4530)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instructions for use for the align radial head system states the following: "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)." "the patient must be cautioned, preferably in writing, about the use, limitations and possible adverse effects of this device including the possibility of device or treatment failure as result of loose fixation and/or 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." "seek medical help immediately if implant malfunctions." the radial head prosthesis was able to function normally in the patient for at least two years prior to the traumatic event which occurred in 2020.The at that time surgeon did not observe any issues with the implanted radial head construct and the patient, a very active carpenter and sports player, only reported an issue with their elbow in 2025 after playing tennis.However, the extent of metal debris and wear to the radial stem found during removal clearly indicate that the construct had failed much earlier, potentially even as a result of the incident in 2020.
Event or Problem Description
An align radial head which had been implanted for over seven years was removed due to movement of the radial head around the stem.

• 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: 22947521
• Report Number: 3006742481-2025-00007
• Device Sequence Number: 13042747
• Product Code: KWI
• UDI-Device Identifier: 00841506100050
• UDI-Public: 00841506100050
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K172688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• 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): 09/02/2025

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: AN1608004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2025
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2016
• 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: 46 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White