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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED LOCKING CAP, BN

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GLOBUS MEDICAL, INC. CREO; CREO THREADED LOCKING CAP, BN Back to Search Results
Model Number 1119.0011
Device Problem Migration (4003)
Patient Problem Failure of Implant (1924)
Event Date 12/12/2018
Event Type  malfunction  
Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was not returned for evaluation as it was retained by the hospital.No determinations can be made as to the cause of the reported issue.
 
Event Description
It was reported that one month post-operatively, a creo threaded locking cap at l5 had backed out requiring revision surgery.
 
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Brand Name
CREO
Type of Device
CREO THREADED LOCKING CAP, BN
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 Key18832552
MDR Text Key336829558
Report Number3004142400-2018-00064
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00889095306491
UDI-Public00889095306491
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K124058
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
Report Date 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
Device Operator Health Professional
Device Model Number1119.0011
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/10/2018
Initial Date FDA Received03/04/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexMale
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