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

Device Problem Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

It was reported that on an unknown date, the surgeon had a couple of non union humerus fracture cases for revision.One was for sure a stryker construct and the other had an unknown manufacturer plates and screws.It is unknown if the procedure was completed successfully.There were patient consequences.Reference report: mw5119160.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

Event Description

It was reported that on an unknown date, the surgeon had a couple of non union humerus fracture cases for revision.One was for sure a stryker construct and the other had an unknown manufacturer plates and screws.It is unknown if the procedure was completed successfully.There were patient consequences.Reference report: mw5119160.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PLATE
• Type of Device: PLATE, FIXATION, BONE
• MDR Report Key: 17278421
• MDR Text Key: 318616921
• Report Number: MW5119159
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2023
• Patient Sequence Number: 1