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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 Problems Fracture (1260); Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 05/19/2021
Event Type  malfunction  
Manufacturer Narrative
The devices were not available for evaluation as they remain in the patient.Imaging provided shows a displaced locking cap and fractured screw shank.The exact cause of the reported issue could not be determined.
 
Event Description
It was reported that a locking cap popped off and a screw came loose and fractured post-operatively.
 
Manufacturer Narrative
Evaluation of the hardware received shows wear and markings consistent with normal use.Imaging provided shows a displaced locking cap and fractured screw shank.It was determined during the surgery that the patient had significant osteoporosis which may have been a contributing factor.The exact cause of the reported issue could not be determined.
 
Event Description
It was reported that a revision surgery was completed due to a locking cap popping off, and a screw loosening and fracture post-operatively.
 
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Brand Name
CREO
Type of Device
CREO FENESTRATED, MIS LOCKING CAP
Manufacturer (Section D)
GLOBUS MEDICAL, INC.
2560 general armistead avenue
audubon 19403
MDR Report Key11778759
MDR Text Key251663558
Report Number3004142400-2021-00084
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K172269
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 06/15/2021
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 Number1192.0020
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2021
Initial Date Manufacturer Received 04/08/2021
Initial Date FDA Received05/05/2021
Supplement Dates Manufacturer Received04/08/2021
Supplement Dates FDA Received06/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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