MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. INDEPENDENCE MIS; THREADED ROD

Model Number 6135.0010

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/09/2023

Event Type  malfunction  

Manufacturer Narrative

The device could not be returned for evaluation.The imaging provided shows the threaded rod in the inserter snapped off at the implant.Though the use of the additional threaded rod as added leverage is a possible cause, the shearing at the threaded tip suggests excessive force either when loading the implant on the inserter or implanting the device resulted in the threads binding which necessitated excessive force to detach from the inserter though this cannot be verified.However, an exact cause of the reported issue could not be determined.

Event Description

It was reported that during a surgery an independence mis threaded rod broke off into a cage and was left in the patient. .

• Brand Name: INDEPENDENCE MIS
• Type of Device: THREADED ROD
• 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: 16294799
• MDR Text Key: 308835952
• Report Number: 3004142400-2023-00017
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160597
• 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: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6135.0010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• 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: 73 YR
• Patient Sex: Male