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

Catalog Number	ALN-RHI-240
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
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 head alignment tool must be used during the procedure to correctly align the prosthetic head and to provide the necessary counter-torque when tightening the lock screw." "the lock screw packaged with the radial head must be installed and fully tightened to fix the radial head to the radial stem.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." the attending sales rep for the initial case claims that the surgeon had trouble inserting the screw, indicating that it may not have been inserted correctly and/or sufficiently tightened.
Event or Problem Description
The set screw backed out of an implanted align radial head, requiring revision surgery.

• 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: 20217939
• Report Number: 3006742481-2024-00012
• Device Sequence Number: 20706422
• Product Code: KWI
• UDI-Device Identifier: 00841506100043
• UDI-Public: 00841506100043
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K172688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 09/12/2024

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-240
• Device Lot Number: AN2111046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2022
• 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: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Hispanic
• Patient Race: White