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U.S. Department of Health and Human Services

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

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GLOBUS MEDICAL, INC. CREO MIS STABILIZATION SYSTEM; LOCKING CAP DRIVER Back to Search Results
Model Number 6134.0185
Device Problem Material Fragmentation (1261)
Patient Problem Insufficient Information (4580)
Event Date 04/06/2021
Event Type  malfunction  
Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Neither the device or any imaging could be provided for evaluation.The failure reported is consistent with excessive forces; however, no determinations could be made as to the cause of the reported issue.
 
Event Description
It was reported that during surgery the tip of the creo mis locking cap driver was broken and left in the patient.This event occurred in australia.
 
Event Description
It was reported that during surgery the tip of the creo mis locking cap driver was broken and left in the patient.This event occurred in australia.
 
Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Neither the device or any imaging could be provided for evaluation.The failure reported is consistent with excessive forces; however, no determinations could be made as to the cause of the reported issue.The following sections have been updated.B4, e1, h2, h6, h10.B4, e1, g6, h2, h10.
 
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Brand Name
CREO MIS STABILIZATION SYSTEM
Type of Device
LOCKING CAP DRIVER
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 Key18834287
MDR Text Key337210639
Report Number3004142400-2023-00074
Device Sequence Number1
Product Code LXH
UDI-Device Identifier00889095178289
UDI-Public00889095178289
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
D154976
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/26/2024
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
Device Model Number6134.0185
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/28/2023
Initial Date FDA Received03/05/2024
Supplement Dates Manufacturer Received03/28/2023
Supplement Dates FDA Received08/27/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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