MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED 8.5X120MM POLYAXIAL SCREW, COCR HEAD, TI SHANK,

Model Number	5146.1818
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during follow up, the surgeon noticed on fluoro imaging that two pelvic screws had fractured.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The anterior-posterior fluoro image which was provided shows that the iliac screws have fractured bilaterally at the neck of the screw.An additional superior iliac screw on the left side remains intact.The implants were not available for evaluation as they remain in the patient.It's possible overload of the implants by cyclic patient loading or an unreported traumatic event, unknown intraoperative conditions which may have introduced a notch or stress concentration on the neck of the screw, or patient factors such as an infection adjacent to the broken implant may have contributed to the observed breakage.Without evaluating the physical devices, the exact cause of the reported issue cannot be determined.The following sections have been updated.B4, e1, h2, h6, h10.

• Brand Name: CREO
• Common Device Name: CREO THREADED 8.5X120MM POLYAXIAL SCREW, COCR HEAD, TI SHANK,
• 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: 18832005
• Report Number: 3004142400-2019-00029
• Device Sequence Number: 7796067
• Product Code: NKB
• UDI-Device Identifier: 00889095130393
• UDI-Public: 00889095130393
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 03/04/2024

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: 5146.1818
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Hispanic