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

Model Number 1192.0020

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 08/31/2021

Event Type  malfunction  

Manufacturer Narrative

Neither device or any imaging could be provided for evaluation.No determinations can be made as to the cause of the reported issue.

Event Description

It was reported that a revision surgery was done for a creo mis locking cap that had migrated into the muscle post-operatively, causing patient pain.This event occurred in (b)(6).

Event Description

It was reported that a revision surgery was done for a creo mis locking cap that had migrated into the muscle post-operatively, causing patient pain.This event occurred in belgium.

Manufacturer Narrative

Four creo fenestrated mis locking caps were received.Investigation revealed that all locking caps show wear markings on their bottom surface similar to markings observed in typical final tightening, with the exception of possibly increased wear marks on locking cap bottom outer edges.The exact cause of the reported issue cannot be determined.

• Brand Name: CREO FENESTRATED SCREW SYSTEM
• Type of Device: CREO FENESTRATED, MIS 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 ; 6109301822
• MDR Report Key: 12683142
• MDR Text Key: 281129042
• Report Number: 3004142400-2021-00205
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D319117
• 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: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1192.0020
• Device Lot Number: BAY333JA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Date Manufacturer Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2021
• 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