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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED 6.5X45MM POLYAXIAL SCREW
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GLOBUS MEDICAL, INC. CREO; CREO THREADED 6.5X45MM POLYAXIAL SCREW Back to Search Results
Model Number 5119.1647
Health Effect - Clinical Code Complaint, Ill-Defined (2331)
Date of Event 11/04/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Neither the device or any imaging could be provided for evaluation.No determinations can be made as to the cause of the reported issue.
 
Event or Problem Description
It was reported by a representative from (b)(6) that a revision surgery was done to replace 2 of 3 screws which had deviated post-operatively causing adverse effects to the patient.
 
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Brand Name
CREO
Common Device Name
CREO THREADED 6.5X45MM POLYAXIAL SCREW
Manufacturer (Section D)
GLOBUS MEDICAL, INC.
2560 general armistead avenue
audubon 19403
MDR Report Key10962609
Report Number3004142400-2020-00156
Device Sequence Number16761715
Product Code MNH
UDI-Device Identifier00889095104158
UDI-Public00889095104158
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K124058
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
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) 12/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number5119.1647
Device Lot NumberLWW319DH/LWW354EH
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/09/2020
Initial Report FDA Received Date12/07/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age52 YR
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