MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO FENESTRATED SCREW SYSTEM; CREO FENESTRATED, LOCKING CAP, THREADED

Model Number 1192.0010

Device Problems Migration or Expulsion of Device (1395); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 08/17/2022

Event Type  malfunction  

Manufacturer Narrative

The device was not available for evaluation as it was discarded by the hospital.The imaging provided shows that the left l2 locking cap had loosened and dissociated from the left l2 pedicle screw resulting in the rod dissociating from the left l2 pedicle screw.No determinations could be made as to the cause of the reported issue.

Event Description

It was reported there was a revision surgery due to a creo fenestrated locking caps that was loose 8 months post operatively causing patient pain and subsequent rod migration.

• Brand Name: CREO FENESTRATED SCREW SYSTEM
• Type of Device: CREO FENESTRATED, LOCKING CAP, THREADED
• 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: 15413422
• MDR Text Key: 300591050
• Report Number: 3004142400-2022-00135
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889095541656
• UDI-Public: 00889095541656
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/02/2022

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
• Device Model Number: 1192.0010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 85 YR
• Patient Sex: Female