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

Model Number	1119.0110
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Evaluation of the returned devices found the clamps and saddle of the screw head attached to the screw.Wearing of the anodized coating can be seen on the amp saddle and a cylindrical impression can be seen across the high points of the saddle, perpendicular to the saddle's rod slot.The screw head, looking cap, and curved rod were returned still assembled.The screw head was missing the saddle and clamps which were attached to the screw.The curved rod was fully seated in the screw head's rod slot with no space between the rod and screw head.The locking cap was in full contact with the curved rod and the top of the locking cap was countersunk below the top surface of the screw head.The observed damage to the screw head is indicativeof abnormal or excessive force.The cylindrical impression on the saddle indicates that the saddle may have been rotated out of position as the marks were perpendicular to the rod slot.This could have resulted in excessive compression and translation of the internal components.Additionally, excessive loading.Of the implants post-operatively may have contributed to the reported issue.However, the exact cause cannot be determined.
Event or Problem Description
It was reported that a creo amp threaded screw head disassociated from the screw shank post-operatively.This resulted in the loss of correction of spondylolisthesis.The patient was revised using creo threaded fenestrated screws and fortress cement.

• Brand Name: CREO
• 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: 18820154
• Report Number: 3004142400-2020-00001
• Device Sequence Number: 8308129
• 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: 2019
• Device Explanted Year: 2019
• 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): 03/01/2024

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: BAW097KG
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2019
• 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 Age: 69 YR
• Patient Sex: Male
• Patient Weight: 119 KG
• Patient Race: White