MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RISE; RISE SPACER

Model Number	193.103
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implant remains in the patient, and therefore no evaluation can made.Based on the images provided, there appears to be a partial loss of height.It cannot be determined what the implant's current height is and how it compares to when the implant was implanted.No determinations as to the cause of the partial loss of height can be determined.
Event or Problem Description
It was reported that a post-op scan revealed the rise spacer had collapsed.

• Brand Name: RISE
• Common Device Name: RISE SPACER
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon 19403 ; 6109301800
• MDR Report Key: 7013357
• Report Number: 3004142400-2017-00062
• Device Sequence Number: 19728215
• Product Code: MAX
• UDI-Device Identifier: 00889095213522
• UDI-Public: 00889095213522
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2017

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: 193.103
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2017
• Supplement Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 11/09/2017
• Supplement Report FDA Received Date: 11/09/2017
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 44 KG