MAUDE Adverse Event Report: MEDICAL PLATE ; PLATE, FIXATION, BONE

Catalog Number DON'T KNOW

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Erythema (1840); Failure of Implant (1924); Unspecified Infection (1930); Swelling (2091)

Event Date 11/30/2018

Event Type  Injury  

Event Description

I felt at home and broke my arm i was taken to the hosp and was operated.A medical plate with screws was implanted.After a month and two wks, my arm got swollen and reddening on the outside.I developed a very serious infection and was put on oral and intravenous antibiotics and hospitalized for 16 days.The plate and screws had to be removed.One of the screws had come out on its own and caused at this ordeal and suffering.Till this day, my arm is incapacitated.I had four operations and still waiting for a fifth.It is almost a year since my accident and my arm is unable to be used.Fda safety report id# (b)(4).

• Brand Name: MEDICAL PLATE
• Type of Device: PLATE, FIXATION, BONE
• MDR Report Key: 9147054
• MDR Text Key: 161358679
• Report Number: MW5090183
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/29/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: DON'T KNOW
• Device Lot Number: DON'T KNOW
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 62 YR
• Patient Weight: 77