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

Catalog Number	ALN-RHI-220
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The set screw backed out of an implanted align radial head, requiring revision surgery.
Additional Manufacturer Narrative
The instructions for use for the align radial head system includes the following warnings: "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 a 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." in the years following initial implantation, the patient engaged in 'hardcore' activity.Compounded by the patient's potential obesity, the radial head construct was likely stressed, causing the set screw affixing the radial head to the radial stem to back out.

• 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 (Section G): 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: 19093366
• Report Number: 3006742481-2024-00006
• Device Sequence Number: 18036284
• Product Code: KWI
• UDI-Device Identifier: 00841506100043
• UDI-Public: 00841506100043
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K172688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• 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): 04/10/2024

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
• Device Catalogue Number: ALN-RHI-220
• Device Lot Number: AN2002019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 04/11/2024
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 136 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White