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

Model Number 1119.0010

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 11/11/2022

Event Type  malfunction  

Event Description

It was reported that a revision surgery was needed to remove (4) creo threaded locking caps that were loose 1 week post operatively.

Manufacturer Narrative

The locking caps were returned for evaluation.Three of the four caps had wear on the bottom that is consistent with wear during final tightening onto a rod.There was evidence on these three caps of wear in the drive feature also consistent with final tightening.The imaging provided was inconclusive about the caps, but rod migration could be seen.It was reported that the patient fell and heard a "pop".The patient is obese with high bmi of 46.3.With a high bmi and the typical force of a fall postoperatively, this is consistent with excessive force placed on the construct, which may have been a contributing factor; however, a cause of the reported issue could not be determined.

• Brand Name: CREO STABILIZATION SYSTEM
• 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: 15972127
• MDR Text Key: 306701224
• Report Number: 3004142400-2022-00180
• 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
• Report Date: 12/08/2022

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: 1119.0010
• Device Lot Number: BAA599FD/BAA595LD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2022
• 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: 45 YR
• Patient Sex: Female
• Patient Race: White