MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 1134.7060

Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 02/09/2021

Event Type  Injury  

Event Description

Approximately 6 weeks post procedure, x-ray demonstrated migration of the right sided rod and retropulsion of bone graft material in the right lateral recess at the l4/l5.Initial post-operative x-ray demonstrates the hardware was in place post-procedure.The patient required a take back to clean out the graft material, explantation of the migrated hardware and new rode and set screw placement.

• Brand Name: CREO
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead ave; valley forge business center; audubon PA 19403
• MDR Report Key: 11503933
• MDR Text Key: 240335141
• Report Number: 11503933
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1134.7060
• Device Catalogue Number: 1134.7060
• Device Lot Number: JNV725HB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2021
• Device Age: 2 MO
• Event Location: Other
• Date Report to Manufacturer: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 26280 DA
• Patient Weight: 74