MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO STABILIZATION SYSTEM; CREO AMP THREADED POLYAXIAL TULIP

Model Number	1119.0110
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a revision surgery due to (2) screw heads failing post operatively.
Additional Manufacturer Narrative
The device was not available for evaluation as it was discarded by the hospital.The post operative imaging provided from the original surgery shows both the left and right s2 screws heads had dissociated from their screw shanks.The imaging provided of the explanted s2 amp screw heads showed that they were subjected to excess force consistent with head pull-off.One implant was missing its internals and the second implant had internals that were significantly exposed with evidence of lateral deformation.Pseudoarthrosis at l5-s1 was noted during the revision surgery.It is possible the screw head dissociation is a result of excess bending forces on the subject s2 implants resulting from inadequate fixation, both from pseudoarthrosis and the lack of s1 fixation at the time of original implantation.However, an exact cause to the reported issue could not be determined.

• Brand Name: CREO STABILIZATION SYSTEM
• Common Device Name: CREO AMP THREADED POLYAXIAL TULIP
• 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: 14455306
• Report Number: 3004142400-2022-00074
• Device Sequence Number: 5050603
• Product Code: MNH
• UDI-Device Identifier: 00889095059656
• UDI-Public: 00889095059656
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K124058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2022

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
• Operator of Device: Health Professional
• Device Model Number: 1119.0110
• Device Lot Number: BAX010DG/BAX153NG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown