MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. PLYMOUTH; PLYMOUTH SCREW

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

The device was not available for evaluation.On july 18, 2023 one rise-l spacer was implanted into the l4/l5 disc space, supplemented by a plymouth lateral plate and 3 bone screws (2 screws placed in the inferior l5 vertebral body, and 1 screw placed in the superior l4 vertebral body.The cage was expanded and the procedure was completed successfully.On feb.6, 2024, it was reported that the bone screw had fractured, and the rise-l spacer had collapsed within the disc space.The provided imaging suggests that the self-locking mechanism of the rise-l spacer had failed, potentially causing the implant to collapse and subjecting the superior bone screw to increased bending loads.There are no current plans to remove the fractured screw or plate/spacer.According to email correspondence from the patient, additional surgery is planned for (b)(6), 2024, however the surgeon plans to work around the plate and not remove it.It is likely the self-locking feature of the rise-l implant failed, causing excessive loading and subsequent fracture of the bone screw, however an exact cause could not be established from the provided information and post-operative imaging.The failure-mode of the parts could not be evaluated in detail as they remain in the patient, and so the complaint is indeterminate.No determinations could be made as to the cause of the reported issue.

Event Description

It was reported that a plymouth screw has broken with subsequent implant collapse post operatively.

• Brand Name: PLYMOUTH
• Type of Device: PLYMOUTH SCREW
• 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: 18849841
• MDR Text Key: 337621200
• Report Number: 3004142400-2024-00043
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Male