MAUDE Adverse Event Report: SKELETAL DYNAMICS LLC ALIGN RADIAL HEAD; RADIAL HEAD PROSTHESIS

Model Number ALIGN RADIAL STEM

Device Problem Detachment Of Device Component (1104)

Patient Problems Discomfort (2330); Foreign Body In Patient (2687)

Event Date 06/12/2015

Event Type  malfunction  

Event Description

Patient complained of some discomfort in her elbow.X-rays reveal a foreign mass in the elbow that may be the set screw but cannot be confirmed.The implant appears to be intact and the patient has full range of motion.The doctor and the patient have elected not to explant the device at this time.

Manufacturer Narrative

Current information is insufficient to permit a final definitive conclusion as to the cause of the event.At this time we cannot confirm that the foreign body is a part of the implant.Calibration records were reviewed for the torque handle used in the device.The handle has consistently tested within specifications throughout the life of the device.

• Brand Name: ALIGN RADIAL HEAD
• Type of Device: RADIAL HEAD PROSTHESIS
• Manufacturer (Section D): SKELETAL DYNAMICS LLC; 8905 sw 87th ave suite 201; miami FL 33176
• Manufacturer Contact: mario arbesu ; 8905 sw 87th ave suite 201; miami, FL 33176 ; 3055967585
• MDR Report Key: 4925915
• MDR Text Key: 6430054
• Report Number: 3006742481-2015-00002
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Model Number: ALIGN RADIAL STEM
• Device Catalogue Number: ALN-RHI-180
• Device Lot Number: AN0212001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 68