MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CAPTIVATE; CAPTIVATE-VL TI 2.5MM X 10-12MM LONG BONE THREAD CANNULATED SCREW

Device Problems Fracture (1260); Improper or Incorrect Procedure or Method (2017); Material Twisted/Bent (2981)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Manufacturer Narrative

Neither the device nor any imaging was available for evaluation.The most likely cause of the screw bending in vivo was patient non-compliance with excessive force applied to the implant post-operatively.However, the exact cause of the reported issue could not be determined.

Event Description

It was reported that a revision surgery was done to remove and replace a screw that was bent post-operatively and repair a second fracture.The screw bend and second fracture were due to failure to follow post-op instructions as the patient exerted excessive force on the implant.

• Brand Name: CAPTIVATE
• Type of Device: CAPTIVATE-VL TI 2.5MM X 10-12MM LONG BONE THREAD CANNULATED SCREW
• 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: 12280176
• MDR Text Key: 267047687
• Report Number: 3004142400-2021-00140
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D299668
• 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: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 08/05/2021
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other