MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CERVICAL INSTRUMENTS; NARROW IMPLANT HOLDER

Model Number 614.805

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The instrument was returned for evaluation and was observed to be missing one of the two prongs that engage with the implant assembly.Investigation found the surgeon used a kocher knob to turn the knurled knob counterclockwise in an effort to disengage the narrow implant holder from lhe implant.The use of a kocher may have applied unnecessary torsion on the prong leading to it breaking.It is unclear as to the exact cause of the holder becoming stuck to the implant assembly.The following sections have been updated for this supplemental report: b4, e1, h2, h6, h10.

Event Description

It was reported that the narrow implant holder became stuck to the secure-c assembly after insertion into the patient.The instrument broke in the process of removal and there was external damage to the patient's endplates.

• Brand Name: CERVICAL INSTRUMENTS
• Type of Device: NARROW IMPLANT HOLDER
• 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: 18809737
• MDR Text Key: 336582384
• Report Number: 3004142400-2019-00049
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/28/2024

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
• Device Operator: Health Professional
• Device Model Number: 614.805
• Device Lot Number: FAU335CD
• Initial Date Manufacturer Received: 06/17/2019
• Initial Date FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Race: Black Or African American