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

Model Number ALIGN Radial Stem, 10mm x 0mm

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

The complainant part is not expected to be returned and therefore no physical investigation could be performed.Based on the limited information available, no conclusion could be drawn at the time of filing this report.

Event Description

Broken stem.

• Brand Name: ALIGN
• Type of Device: 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: 12522609
• MDR Text Key: 273130203
• Report Number: 3006742481-2019-00005
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 00841506100210
• UDI-Public: 00841506100210
• 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: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ALIGN Radial Stem, 10mm x 0mm
• Device Catalogue Number: ALN-RST-1000
• Device Lot Number: AN0913063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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