MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. REVERE; 5.5MM PRE-CONTOURED ROD, 450MM

Model Number	124.400
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Evaluation of the provided x-rays show the rods broke bilaterally just cephalad to the head offset connectors joining the rods to the iliac bolts between the ls and s1 screws.This is an area of high stress as the head offset connectors are connecting the spine to the ilium.The long fixation construct above also creates a large lever arm, further stressing the bottom of the construct at s1.Additionally, the double screw head had come disconnected from the bone screw.It was reported that the patient has pseudoarthrosis at l5-s1 which indicates this segment had not fused, and the construct continued to carry some of the load at this level.The rods were returned for evaluation and the fracture surfaces of the rods were found to be consistent with fatigue fracture.The diameter of the rod segments was measured in the area of the fracture and found to be within specification.It is possible that the high stress concentration in this area caused a fatigue fracture in the rods.This is consistent with the pseudoarthrosis at this level resulting in continuous motion.The patient also underwent 3 previously failed spinal surgeries.No information was available regarding these surgeries.It is possible that factors associated with these previous surgeries also contributed, such as a previous fusion at the treated levels.However, it is not possible to determine the exact cause of the reported issue.
Event or Problem Description
It was reported that a revision surgery was required due to two broken rods at the lateral connectors, connected to the iliac screws, just above the double screw heads which had also disassociated form the shank.

• Brand Name: REVERE
• Common Device Name: 5.5MM PRE-CONTOURED ROD, 450MM
• 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: 18828746
• Report Number: 3004142400-2019-00039
• Device Sequence Number: 14214945
• Product Code: MNH
• UDI-Device Identifier: 00889095038279
• UDI-Public: 00889095038279
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K121922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 124.400
• Device Lot Number: BGV127KD
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2018
• 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: Female
• Patient Race: White