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

Model Number ALIGN Radial Stem, 7mm x 0mm

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 08/08/2022

Event Type  malfunction  

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 Description

A screw disengaged from a radial head implant.The implant was removed.No patient injury occured.

• Brand Name: SKELETAL DYNAMICS
• Type of Device: 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
• MDR Text Key: 305601013
• Report Number: 3006742481-2022-00008
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 00841506100067
• UDI-Public: 00841506100067
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172688
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ALIGN Radial Stem, 7mm x 0mm
• Device Catalogue Number: ALN-.RST-XXX
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 74 KG