MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RISE SPACER 10X22MM, 8-14MM, 10 DEGREE

Model Number 193.121

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/07/2016

Event Type  malfunction  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The product was not returned for evaluation.A thorough review could not be conducted as no lot number was provided.The implant is not available for evaluation as it remains in the pt.Globus has been in contact with the surgeon, who is going to order ct images for the pt.It was reported the pt is asymptomatic.A supplemental report will be filed if and when additional info becomes available, or if a revision surgery takes place.

Event Description

It was reported to globus that a pt had a loss of height of a rise implant.The initial surgery was (b)(6) 2014 and there is no revision surgery scheduled at this time.

• Brand Name: RISE SPACER 10X22MM, 8-14MM, 10 DEGREE
• Type of Device: RISE SPACER 10X22MM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead ave.; audubon PA 19403
• Manufacturer Contact: daniel paul, vice president ; 2560 general armistead ave.; audubon, PA 19403 ; 6109301800
• MDR Report Key: 5419005
• MDR Text Key: 38089960
• Report Number: 3004142400-2016-00001
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 193.121
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2016
• 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): Other
• Patient Age: 65 YR