MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ZYFUSE FACET FIXATION SYSTEM; ZYFUSE HA COMPRESSION SCREW, 5MMX40MM WITH WASHER

Model Number	147.541S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was a revision surgery to replace a zyfuse ha compression screw that was broken at l4/l5 post operatively.This event occurred in the united kingdom.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was returned for evaluation.Microscopic evaluation of the specimen under 8x magnification revealed two mechanical deformities, consistent with removal.Disassembly was caused by unthreading the compression nut past the retaining features on the posted screw.No determinations could be made as to the cause of the reported issue.

• Brand Name: ZYFUSE FACET FIXATION SYSTEM
• Common Device Name: ZYFUSE HA COMPRESSION SCREW, 5MMX40MM WITH WASHER
• 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: 18834286
• Report Number: 3004142400-2023-00075
• Device Sequence Number: 12622300
• Product Code: MRW
• UDI-Device Identifier: 00889095334111
• UDI-Public: 00889095334111
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K090952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 03/02/2024

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: 147.541S
• Device Lot Number: GBU361HF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2017
• 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: Male