MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RISE SPACER 8 X 26MM, 7-14MM

Model Number 193.002

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 06/11/2014

Event Type  malfunction  

Event Description

It was reported pt underwent revision surgery due to reported collapse of a rise implant.The revision surgery took place (b)(6) 2014.Initial surgery was (b)(6) 2013.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The product was returned for eval, a review was conducted of all applicable material records, mfg records, storage records, and distribution records according to the descriptions of the product used with the concomitant device.All records revealed all product lots were manufactured within specs, maintained and distributed in accordance with all federal, state an operating procedures.The returned implant was visually inspected, and was still intact, dimensionally accurate and functional.The implant was disassembled to evaluate the internal components, and all components were intact.The drive screw and back ramp components measured within tolerance.All films available do not show any unusual representation of the implant.The exact cause of the reported loss of height cannot be ascertained.

• Brand Name: RISE SPACER 8 X 26MM, 7-14MM
• Type of Device: RISE SPACER
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead ave; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead ave.; audubon, PA 19403 ; 6109301800
• MDR Report Key: 3983289
• MDR Text Key: 4749283
• Report Number: 3004142400-2014-00031
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 193.002
• Device Lot Number: WTM336EB
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/16/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2011
• 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: 47 YR