MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. MONUMENT; MONUMENT SPACER

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/28/2016

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The product was not returned for evaluation, and thorough review could not be completed as no part number or lot number was provided.Since the broken implant was not removed from the patient, no evaluation could be performed.It was reported there was a non- union, and this may have contributed to the breakage.The x-rays provided indicate a breakage midway between the head and tip of the screw.There have been no prior reports of screw breakage of this implant.The exact cause of the reported issue could not be determined.Implant remains in patient.

Event Description

It was reported to globus that a patient needed revision surgery due to the breakage of a monument implant screw.The broken screw in the monument spacer was not removed.The surgeon simply removed the l5-s1 posterior screws (6.5mm x 40mm) and replaced them with 8.5mm x 40mm) screws.No other instrumentation was done.The revision surgery took place (b)(6) 2016.Exact date of initial surgery is unknown.

• Brand Name: MONUMENT
• Type of Device: MONUMENT SPACER
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19430 ; 6109301800
• MDR Report Key: 5682458
• MDR Text Key: 46022626
• Report Number: 3004142400-2016-00020
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Weight: 86