MAUDE Adverse Event Report: ADVANCED ORTHOPAEDIC SOLUTIONS, INC. AOS ALPHA PLATE, LEFT, 14 HOLE; PROXIMAL HUMERAL PLATE

Model Number 3024-014

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 01/20/2021

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2021 aos received a report that there was a breakage of a proximal humeral plate (3024-014) inside the patient, 5 weeks post-surgery.Additionally, the breakage of a screw (8110-028 or 8110-030) was reported.There was no information available for the mechanism of failure for the plate.The original date of surgery was (b)(6) 2020.The initial surgery was to correct a anterior lateral proximal humeral fracture.It was reported by the surgeon that the plate and screw may have been used when a nail was considered more appropriate to treat the fracture, but there are no evidence to show the initial fracture pattern of the surgery.More information was requested to see if a revision surgery was scheduled or planned.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

On (b)(6) 2021 aos received a report that there was a breakage of a proximal humeral plate (3024-014) inside the patient, 5 weeks post-surgery.Additionally, the breakage of a screw (8110-028 or 8110-030) was reported.There was no information available for the mechanism of failure for the plate.The original date of surgery was (b)(6) 2020.The initial surgery was to correct a anterior lateral proximal humeral fracture.It was reported by the surgeon that the plate and screw may have been used when a nail was considered more appropriate to treat the fracture, but there are no evidence to show the initial fracture pattern of the surgery.More information was requested to see if a revision surgery was scheduled or planned.

• Brand Name: AOS ALPHA PLATE, LEFT, 14 HOLE
• Type of Device: PROXIMAL HUMERAL PLATE
• Manufacturer (Section D): ADVANCED ORTHOPAEDIC SOLUTIONS, INC.; 3203 kashiwa street; torrance CA 90505
• Manufacturer Contact: alexie mejia ; 3203 kashiwa street; torrance, CA 90505 ; 3105339966
• MDR Report Key: 11344954
• MDR Text Key: 232631377
• Report Number: 2032480-2021-00001
• Device Sequence Number: 1
• Product Code: KTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160409
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3024-014
• Device Catalogue Number: 3024-014
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2021
• 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: 56 YR