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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO MIS LOCKING CAP
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GLOBUS MEDICAL, INC. CREO; CREO MIS LOCKING CAP Back to Search Results
Model Number 1134.0010
Device Problems Loose or Intermittent Connection (1371); Positioning Problem (3009)
Patient Problem Insufficient Information (4580)
Event Date 05/24/2021
Event Type  malfunction  
Manufacturer Narrative
Neither the device nor any imaging was available for evaluation.The device remains in the patient.No determinations could be made as to the cause of the reported issue.
 
Event Description
It was reported that creo mis set screws loosened post-operatively and caused a rod to displace.
 
Manufacturer Narrative
Evaluation of the suspect device shows wear and markings consistent with normal use.Imaging provided shows a single rod to have migrated entirely out of original construct.The exact cause of the reported issue could not be determined.
 
Event Description
It was reported that revision surgery was completed due to creo mis set screws loosening post-operatively and causing a rod to displace.
 
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Brand Name
CREO
Type of Device
CREO MIS LOCKING CAP
Manufacturer (Section D)
GLOBUS MEDICAL, INC.
2560 general armistead avenue
audubon 19403
MDR Report Key11923775
MDR Text Key257694864
Report Number3004142400-2021-00096
Device Sequence Number1
Product Code MNH
Combination Product (y/n)N
PMA/PMN Number
D201515
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 06/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1134.0010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2021
Date Manufacturer Received06/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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