MAUDE Adverse Event Report: CONVENTUS ORTHOPAEDICS PROXIMAL HUMERUS CAGE; PLATE, FIXATION, BONE

Device Problem Insufficient Information (3190)

Patient Problem Non-union Bone Fracture (2369)

Event Date 01/23/2019

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2019, the patient underwent a hardware removal of a proximal humerus plate, 3.5 locking compression plate(lcp) reconstruction plate, five (5) cortex screws, ten (10) locking screws, and a conventus proximal humerus cage due to nonunion.The patient sustained an injury on (b)(6) 2016 and had a surgery for primary repair at an unknown date and another for nonunion at an unknown date.The surgeon noticed this particular nonunion on (b)(6) 2018.It is unknown if there is surgical delay.Procedure outcome and patient status in unknown.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PROXIMAL HUMERUS CAGE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): CONVENTUS ORTHOPAEDICS
• MDR Report Key: 17528688
• MDR Text Key: 321076941
• Report Number: MW5135618
• 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: Other
• Type of Report: Initial
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1