MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RISE; RISE SPACER, 10X26MM, 8-15MM, 10°

Model Number	193.122
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device or any imaging could be provided for evaluation.It is possible that the reported issue occurred due to excessive contraction torque when repositioning the implant, as there is no torque-limit on the handle for this direction; however, an exact cause could not be determined.
Event or Problem Description
It was reported that an assembled rise implant broke apart while being repositioned, and parts of the implant were left in the patient.This event occurred in japan.

• Brand Name: RISE
• Common Device Name: RISE SPACER, 10X26MM, 8-15MM, 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: 16139600
• Report Number: 3004142400-2023-00007
• Device Sequence Number: 19501258
• Product Code: MAX
• UDI-Device Identifier: 00889095213577
• UDI-Public: 00889095213577
• 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 Implanted Year: 2022
• 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): 01/04/2023

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: 193.122
• Device Lot Number: AXA080PG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2022
• 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 Sex: Unknown
• Patient Race: Asian