MAUDE Adverse Event Report: GLOBUS MEDICAL INC. SECURE C; CHISEL

Model Number 614.756

Device Problems Use of Device Problem (1670); Malposition of Device (2616)

Patient Problem Injury (2348)

Event Date 01/08/2018

Event Type  Injury  

Manufacturer Narrative

Both instruments were evaluated, and found to be within specification.The chisel was functionally tested with the mating instrument 614.506 (trial 13x14, 6 mm), and the chisel fully seated onto the trial as intended.User error may have caused or contributed to the event.The trial listed in concomitant medical products, model # 614.506, 13x14, 6 mm trial lot # vil252of-r, mfg date 09/09/2010, (b)(4).

Event Description

The incident occurred during a disc arthroplasty at the (b)(6) hospital.A 13x14 trial was inserted and properly positioned.The broach chisel was advanced under fluoroscopy.The trial and chisel were advanced too far into the patient's spinal canal, resulting in patient injury.

• Brand Name: SECURE C
• Type of Device: CHISEL
• 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: 7241734
• MDR Text Key: 99044865
• Report Number: 3004142400-2018-00003
• 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: Other
• Type of Report: Initial
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 614.756
• Device Lot Number: VIL223AB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2010
• 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
• Treatment: TRIAL
• Patient Outcome(s): Disability
• Patient Age: 48 YR