MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RISE; INSERTER FORK, 8MM

Model Number	693.011
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a rise spacer was implanted.Lateral imaging found the spacer inserted along the lower end plate of l4.While attempting to change the angle of the spacer with the inserter, one of the prongs at the tip of the instrument broke off within the cavity of the spacer.The spacer was filled with bone graft encasing the broken piece of the instrument.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Evaluation of the instrument found one of the forks that mate with the implant has been broken off.It is likely the observed damage was caused by continued attempts to change the angle of the pacer with the inserter even after experiencing resistance due to the bone graft around the device.This excessive force would have placed a high stress concentration on the fork tabs as they are the only attachment mechanism to the spacer.The exact cause of the reported issue cannot be determined.

• Brand Name: RISE
• Common Device Name: INSERTER FORK, 8MM
• 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: 18832328
• Report Number: 3004142400-2018-00062
• Device Sequence Number: 20817113
• Product Code: LXH
• UDI-Device Identifier: 00889095058185
• UDI-Public: 00889095058185
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: D154976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/04/2024

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: 693.011
• Device Lot Number: TIV080EC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Race: Asian