• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CREO
Type of Device
CREO 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
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? No
Initial Date Manufacturer Received 06/24/2021
Initial Date FDA Received07/23/2021
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 Sequence Number1
Patient Outcome(s) Other;
-
-