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

Model Number 1119.0010

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/26/2022

Event Type  malfunction  

Manufacturer Narrative

The device could not be provided for evaluation as it was discarded by the hospital.The imaging provided show the rod migration slipped out of the l3 screw on the left side.A possible cause of the reported issue is excessive cantilever force being placed on the l3 and l5 screws due to a lack of fixation point at l4 where no screws were placed.However, no determinations could be made as to the cause of the reported issue.

Event Description

It was reported there was a revision surgery to replace 1 creo locking cap that was loose post-operatively with subsequent rod migration from l3 screw head.This event occurred in japan.

Manufacturer Narrative

Five creo locking caps were returned for evaluation.A micro image scan of the threaded locking caps was captured showing heavy damages on the threads on one of the two locking caps.The imaging provided shows rod migration from the l3 screw head.An exact cause of the reported issue could not be determined.

Event Description

It was reported there was a revision surgery to replace 1 creo locking cap that was loose post-operatively with subsequent rod migration from l3 screw head.This event occurred in japan.

• Brand Name: CREO
• Type of Device: CREO THREADED LOCKING CAP
• 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: 15218541
• MDR Text Key: 305050262
• Report Number: 3004142400-2022-00123
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095059496
• UDI-Public: 00889095059496
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124058
• 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: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1119.0010
• Device Lot Number: BAX683RD/BAX065JD/BAX629CD/BAY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2020
• 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: 15 YR
• Patient Sex: Female
• Patient Race: Asian