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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED LOCKING CAP
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GLOBUS MEDICAL, INC. CREO; CREO THREADED LOCKING CAP Back to Search Results
Model Number 1119.0010
Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Weakness (2145)
Event Date 11/28/2020
Event Type  malfunction  
Manufacturer Narrative
Neither the device or any imaging could be provided.No determinations could be made.
 
Event Description
It was reported that a revision surgery was done to revise a construct from t10 to l1 due to locking caps disengaging from the screw heads, a screw backing out at l1, and 2 rods disengaging from the screws at t10-t12 post-operatively, causing patient pain and leg weakness.
 
Manufacturer Narrative
The observed markings on the implants indicate that the implants had loosened from the rod.Possible causes include varying tightening conditions from rod angle, rod bend, reduction, insufficient tightening, or excessive loading.The exact cause of the reported issue could not be determined.
 
Event Description
It was reported that a revision surgery was done to revise a construct from t10 to l1 due to locking caps disengaging from the screw heads, a screw backing out at l1, and 2 rods disengaging from the screws at t10-t12 post-operatively, causing patient pain and leg weakness.
 
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Brand Name
CREO
Type of Device
CREO THREADED LOCKING CAP
Manufacturer (Section D)
GLOBUS MEDICAL, INC.
2560 general armistead avenue
audubon 19403
MDR Report Key11078396
MDR Text Key224754678
Report Number3004142400-2020-00182
Device Sequence Number1
Product Code MNH
UDI-Device Identifier00889095059496
UDI-Public00889095059496
Combination Product (y/n)N
PMA/PMN Number
K124058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1119.0010
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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