MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED LOCKING CAP, BN

Model Number 1119.0011

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Spinal Cord Injury (2432)

Event Date 02/26/2024

Event Type  malfunction  

Event Description

It was reported that a revision was needed to replace creo locking caps that were found loose post operatively.This event occurred in austria.

Manufacturer Narrative

The device was not available for evaluation.It was reported that a revision was needed to replace creo locking caps that were found loose post operatively.This event occurred in austria.The case occurred six weeks postoperativly.The interface between the cocr polyaxial screw head and the 1119.0011 locking cap was no longer fixed.A revision surgery was planned for (b)(6) 2024.The returned images showed a construct that appeared to be t8-l3 pedicle screws and rods with 2 cross connectors.It was reported that this surgery was conducted to correct scoliosis and the left l3 locking cap was seen migrated post-op.It was stated that the patient did not experience pain from the locking cap.It was stated that 1 creo cocr screw 7.5x50mm, 4 creo threaded locking caps, and 1 crosslink connector were to be replaced in a revision surgery scheduled for (b)(6) 2024.The extent of the reported looseness could not be confirmed or evaluated based on the returned ap images.Because the state of the locking cap could not be confirmed and the surgical conditions cannot be replicated, nodetermination could be made as to the cause of the reported issue.

Manufacturer Narrative

The device was available for evaluation.The locking cap and cocr uniplanar screw were returned.Evaluation of the locking cap showed typical wear, especially on the bottom of the cap where the hour glass wear pattern confirms proper final tightening.The blue anodization was worn on the outside of the threads as well as the top of the cap which is also consistent with typical wear from use.There was no evidence of deformation on the cap or the screw head that would cause device migration.Because the surgical conditions cannot be replicated, no determinations could be made as to the cause of the reported issue.

Event Description

It was reported that a revision was needed to replace creo locking caps that were found loose post operatively.This event occurred in austria.

• Brand Name: CREO
• Type of Device: CREO THREADED LOCKING CAP, BN
• 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: 18935122
• MDR Text Key: 338084736
• Report Number: 3004142400-2024-00053
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889095306491
• UDI-Public: 00889095306491
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180210
• 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,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1119.0011
• Device Lot Number: BAY264AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2021
• 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: 24 YR
• Patient Sex: Male