MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. SIGNATURE TLIF SPACER, SMALL, 10MM; SIGNATURE SPACER

Model Number 368.210

Device Problems Break (1069); Mechanics Altered (2984)

Patient Problem Failure of Implant (1924)

Event Date 06/27/2014

Event Type  malfunction  

Event Description

It was reported to globus that during insertion of a signature spacer, the orientation of the implant changed because the stabilizer wheel was not locked properly and the connection was not rigid enough.Upon impaction the implant broke.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The product was not returned for evaluation, and a thorough investigation could not be completed as no lot number was provided.No evaluation could be performed as the removed portion of the implant was discarded at the hospital.Part of the broken implant was left in the patient, as it could not be extracted.It was reported there was no adverse effect to the patient.Should any additional information be received, we will file a supplemental report.

• Brand Name: SIGNATURE TLIF SPACER, SMALL, 10MM
• Type of Device: SIGNATURE SPACER
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead ave.; audubon PA 19403
• Manufacturer Contact: daniel paul, vp - qa & it ; 2560 general armistead ave.; audubon, PA 19403 ; 6109301800
• MDR Report Key: 4004845
• MDR Text Key: 4708777
• Report Number: 3004142400-2014-00035
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 368.210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• 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 Age: 24 YR