MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. QUARTEX; QUARTEX OCCIPITAL PLATE, SMALL

Model Number 1149.9200

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not available for evaluation as it was retained by the hospital.Imaging provided shows the plate has completely separated from the patient's occiput and had to be replaced with occipital clamps.The screws appear to remain captured in the locking feature of the plate.There does not appear to be any implant fracture or functional failure.Additional information provided that the patient had dysplasia of the intramembranous ossification that may have contributed to the plate backing out, and that the patient was non-complaint with the doctor's guidance.

Event Description

It was reported that a revision surgery was done to remove a quartex occipital plate, which had backed out post-operatively.

• Brand Name: QUARTEX
• Type of Device: QUARTEX OCCIPITAL PLATE, SMALL
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon 19403 ; 6109301800
• MDR Report Key: 10847890
• MDR Text Key: 218237068
• Report Number: 3004142400-2020-00154
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 00889095357936
• UDI-Public: 00889095357936
• 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: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1149.9200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2020
• 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: 82 YR