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

Catalog Number ALN-RHI-240

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Metal Related Pathology (4530); Implant Pain (4561)

Event Date 12/09/2022

Event Type  malfunction  

Manufacturer Narrative

This failure was brought to the attention of skeletal dynamics over a year after the explantation date.At this time, no information pertaining to patient behavior following initial implantation was able to be obtained, no images from the original case nor the explantation were provided, and the implant has not been returned or made available for analysis.Therefore, this investigation is currently limited to internal testing and review of records.

Event Description

An align radial head disassociated from the radial stem, requiring removal six months after initial implantation.

• Brand Name: SKELETAL DYNAMICS INC.
• Type of Device: ALIGN RADIAL HEAD SYSTEM
• Manufacturer (Section D): SKELETAL DYNAMICS INC.; 7300 n kendall drive; suite 800; miami FL 33156
• Manufacturer (Section G): SKELETAL DYNAMICS INC.; 7300 n kendall drive; suite 800; miami FL 33156
• Manufacturer Contact: baron villalta ; 7300 n kendall drive; suite 800; miami, FL 33156 ; 3055967585
• MDR Report Key: 18591986
• MDR Text Key: 334652699
• Report Number: 3006742481-2023-00022
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ALN-RHI-240
• Device Lot Number: AN2002015
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2020
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White