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

Model Number ALIGN Radial Head & Lock Screw, 24mm

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); Implant Pain (4561)

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

Customer has indicated that the product will be returned to us for investigation, but it has not been returned yet.The investigation is in process, however, no additional information has been provided at the time of filing this report.The instruction for use state: 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.

Event Description

It was reported that a patient underwent a revision procedure approximately 2 years post implantation due to loosening of the product.The screw had backed out from the radial head causing it to become loose.The head and screw were replaced onto the existing stem.Attempts have been made for additional information and/or the explanted product to be returned but is unavailable at this time of filing the report.

• Brand Name: SKELETAL DYNAMICS
• Type of Device: ALIGN RADIAL HEAD SYSTEM
• Manufacturer (Section D): SKELETAL DYNAMICS; 7300 n. kendall drive; suite 400; miami FL 33156
• Manufacturer (Section G): SKELETAL DYNAMICS; 7300 n. kendall drive; suite 400; miami FL 33156
• Manufacturer Contact: mehr malek ; 7300 n. kendall drive; suite 400; miami, FL 33156
• MDR Report Key: 11517590
• MDR Text Key: 243568916
• Report Number: 3006742481-2021-00003
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 00841506100043
• UDI-Public: 00841506100043
• 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: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALIGN Radial Head & Lock Screw, 24mm
• Device Catalogue Number: ALN-RHI-240
• Device Lot Number: AN1806008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• 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: 64 YR
• Patient Weight: 73