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

Model Number	193.121
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/21/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3004142400-2018-00002
• Device Sequence Number: 15266001
• Product Code: MAX
• UDI-Device Identifier: 00889095213560
• UDI-Public: 00889095213560
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K113447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White