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

Model Number 193.121

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 12/21/2017

Event Type  Injury  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The implant was returned for evaluation.The surgical procedure involved l5-s1 fusion using two rise cages with bilateral cortical screw posterior fixation.It was reported one of the spacers had a loss of height.No pre-operative images, or post­ operative images were provided, therefore any difference in cage height cannot be confirmed without pre-op and post-op images.Both returned spacers show abundant scratching on the anterior sides of the spacers consistent with tools used in the removal of the device.No determination can be made as to the possible loss of height in one of the devices.The initial surgery occurred in (b)(6) 2017, the exact date is unknown.The following sections have been updated in this report: a1, a2, a3, a5, a6, b1, b2, b3.B4, d4, d6b, d10, e1, e3, g2, g3, g4, g6, g7, h2, h3, h6, h8, h10.

Event Description

The patient was 8 months post-op from original surgery and it appears one of the cages collapsed.Removal surgery occurred (b)(6) 2017.

• Brand Name: RISE
• Type of Device: RISE SPACER 10X22MM, 8-14MM, 10°
• 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 19403 ; 6109301800
• MDR Report Key: 18809731
• MDR Text Key: 336582247
• Report Number: 3004142400-2018-00002
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 193.121
• Device Lot Number: WTT074MD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2016
• 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: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White