MAUDE Adverse Event Report: GLOBUS MEDICAL INC. 29 HOLE RIGHT BROAD PLATE; PLATE, FIXATION, BONE

Catalog Number 1195.4229

Device Problem Defective Device (2588)

Patient Problems Emotional Changes (1831); Unspecified Infection (1930); Pain (1994)

Event Type  Injury  

Event Description

Event description: on or about (b)(6) 2022 the patient sustained injuries as a result of trip and fall over a security band on the exterior sidewalk premises of the store.On or about (b)(6) 2022 the surgeon performed a right femur distal fracture surgical repair.On or about (b)(6) 2023 the patient underwent second surgery to replace the depuy hardware installed due to infection related to surgery, depuy hardware was defective in design and/or manufacture and past and present pain and suffering he allegedly sustained.This complaint involves unknown number of devices.Reference reports: mw5144705, mw5144706, mw5144707, mw5144708, mw5144709, mw5144710, mw5144711, mw5144713, mw5144714, mw5144715, mw5144716, mw5144717, mw5144718, mw5144719, mw5144720, mw5144721, mw5144722, mw5144723, mw5144724, mw5144725, mw5144726, mw5144727, mw5144728, mw5144729, mw5144730.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

Event Description

Additional information received for report mw5144712 on 09/13/2023 to update procode to hrs.Reference reports: mw5144705, mw5144706, mw5144707, mw5144708, mw5144709, mw5144710, mw5144711, mw5144713, mw5144714, mw5144715, mw5144716, mw5144717, mw5144718, mw5144719, mw5144720, mw5144721, mw5144722, mw5144723, mw5144724, mw5144725, mw5144726, mw5144727, mw5144728, mw5144729, mw5144730.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: 29 HOLE RIGHT BROAD PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): GLOBUS MEDICAL INC.
• MDR Report Key: 17572063
• MDR Text Key: 321621853
• Report Number: MW5144712
• 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,Followup
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 1195.4229
• Patient Sequence Number: 1