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

Model Number	ALIGN Radial Stem, 7mm x 0mm
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The radial head was originally implanted by a different surgeon 7 years prior to removal.There were no reports of patient injury.The removal and replacement procedure was successful.The initial reporter did not report any issues regarding the patient or the revision.No other information was provided regarding this failure.The device was not returned for evaluation.
Event or Problem Description
A screw disengaged from a radial head implant.The implant was removed.No patient injury occured.

• Brand Name: SKELETAL DYNAMICS
• Common Device Name: ALIGN RADIAL HEAD SYSTEM
• Manufacturer (Section D): SKELETAL DYNAMICS; 7300 n kendall drive; miami FL 33156
• Manufacturer (Section G): SKELETAL DYNAMICS; 7300 n kendall drive; miami FL 33156
• Manufacturer Contact: alejandro ros ; 7300 n kendall drive; miami, FL 33156 ; 3055967585
• MDR Report Key: 15372852
• Report Number: 3006742481-2022-00008
• Device Sequence Number: 19263948
• Product Code: KWI
• UDI-Device Identifier: 00841506100067
• UDI-Public: 00841506100067
• 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 Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace,Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 09/07/2022

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
• Operator of Device: Health Professional
• Device Model Number: ALIGN Radial Stem, 7mm x 0mm
• Device Catalogue Number: ALN-.RST-XXX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 74 KG