MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS

Model Number 1134.0100

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Date 08/16/2019

Event Type  malfunction  

Event Description

Patient returned to the operating room 72 hours status post l4-l5, l5-s1 transforaminal lumbar interbody fusion.Imaging indicated that the left s1 screw tulip had broken off.Lumbar spine hardware revision with removal and replacement of left s1 pedicle screw.

• Brand Name: CREO
• Type of Device: PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead ave; valley forge business center; audubon PA 19403
• MDR Report Key: 9069584
• MDR Text Key: 158629145
• Report Number: 9069584
• Device Sequence Number: 1
• Product Code: OSH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1134.0100
• Device Catalogue Number: 1134.0100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25185 DA