MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. QUARTEX POSTERIOR OCCIPITO-CERVICO-THORACIC STABILIZATION SYSTEM; QUARTEX 4.5MM POLYAXIAL SCREW, 30MM

Model Number 1149.4530

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/31/2022

Event Type  malfunction  

Manufacturer Narrative

Neither the device or any imaging could be returned for evaluation.No determinations could be made as to the cause of the reported issue.

Event Description

It was reported that during a surgery the implant broke and part of it was left inside patient.

• Brand Name: QUARTEX POSTERIOR OCCIPITO-CERVICO-THORACIC STABILIZATION SYSTEM
• Type of Device: QUARTEX 4.5MM POLYAXIAL SCREW, 30MM
• 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: 15945971
• MDR Text Key: 307779888
• Report Number: 3004142400-2022-00178
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 00889095355789
• UDI-Public: 00889095355789
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161591
• 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: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1149.4530
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 62 YR
• Patient Sex: Male