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

Model Number	ALIGN Radial Head & Lock Screw, 24mm
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instructions for use of this device states: the locking screw packaged with the radial head must be installed and fully tightened to fix the radial head to the radial stem.If the locking 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.This is a common cause of failure in radial head cases.However, the returned unit is currently undergoing testing, and a root cause has yet to be determined.
Event or Problem Description
Locking screw of radial head implant loosened.The affected device was removed and a revision procedure was conducted successfully.

• Brand Name: SKELETAL DYNAMICS INC.
• Common Device Name: ALIGN RADIAL HEAD SYSTEM
• Manufacturer (Section D): SKELETAL DYNAMICS INC.; 7300 n kendall drive; miami FL 33156
• Manufacturer (Section G): SKELETAL DYNAMICS INC.; 7300 n kendall drive; miami FL 33156
• Manufacturer Contact: alejandro ros ; 7300 n kendall drive; miami, FL 33156 ; 3055967585
• MDR Report Key: 16797424
• Report Number: 3006742481-2023-00006
• Device Sequence Number: 16928826
• Product Code: KWI
• UDI-Device Identifier: 00841506100043
• UDI-Public: 00841506100043
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Patient Monitoring,Replace
• Type of Report: Initial
• Report Date (Section B): 04/18/2023

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 Model Number: ALIGN Radial Head & Lock Screw, 24mm
• Device Catalogue Number: ALN-RHI-260
• Device Lot Number: AN1909005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White