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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO CREO FENESTRATED, MIS LOCKING CAP

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GLOBUS MEDICAL, INC. CREO CREO FENESTRATED, MIS LOCKING CAP Back to Search Results
Model Number 1192.0020
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
The device was not available as it remains in the patient. The immediate post-operative imaging provided showed the locking caps sitting slightly proud of the screw head. In follow up, additional post-operative images appear to show a rod slip. The exact cause of the reported issue cannot be determined.
 
Event Description
It was reported that a locking cap has loosened post-operatively.
 
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Brand NameCREO
Type of DeviceCREO FENESTRATED, MIS LOCKING CAP
Manufacturer (Section D)
GLOBUS MEDICAL, INC.
2560 general armistead avenue
audubon 19403
Manufacturer (Section G)
GLOBUS MEDICAL, INC.
2560 general armistead avenue
audubon 19403
Manufacturer Contact
daniel paul
2560 general armistead avenue
audubon 19403
6109301800
MDR Report Key12221632
MDR Text Key265353482
Report Number3004142400-2021-00132
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
D319117
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 07/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1192.0020
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/23/2021 Patient Sequence Number: 1
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