MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. TRANSCONTINENTAL; TRANSCONTINENTAL M LLIF SPACER, 20MMX55MM, 20°, 11MM

Model Number	375.822
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was available for evaluation.One transcontinental m implant was reported to have fractured intraoperatively.The reported event occurred on (b)(6), 2024 in germany, during a llif procedure (levels unknown) using an intercontinental plate-spacer construct (transcontinental m cage, intercontinental plate) with lateral mis anchors.During final imaging and visual inspection of the plate-spacer construct in the disc space, it was reported that a break in the transcontinental m cage was detected.The intercontinental plate and lateral mis anchors were removed, as well as loose pieces of peek from the spacer.The bulk of the cage could not be retrieved from the disc space, and the procedure was aborted.It was reported that the patient will undergo further surgery to receive dorsal fixation at this level in the future.The intercontinental plate and lateral mis anchors were returned for evaluation.There were several gouges and dents on the plate's torsional stabilizers, inserter mating features, and blocking screw, as well as damage to the anodization layer.Similarly, dents were observed on the anchors along the central and lateral fins, and around the threaded feature on the proximal end of the part.It could not be established if the observed damage was present prior to implantation, or if the damage occurred during removal.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a transcontinental llif spacer and other globus hardware had to be removed intra-operatively after being placed.This event occurred in germany. .

• Brand Name: TRANSCONTINENTAL
• Common Device Name: TRANSCONTINENTAL M LLIF SPACER, 20MMX55MM, 20°, 11MM
• 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: 19649265
• Report Number: 3004142400-2024-00139
• Device Sequence Number: 20766817
• Product Code: OVD
• UDI-Device Identifier: 00889095219838
• UDI-Public: 00889095219838
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 07/01/2024

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: 375.822
• Device Lot Number: BAU090FB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2017
• 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: Unknown