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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. N/A; LOCKING CAP DRIVER

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GLOBUS MEDICAL, INC. N/A; LOCKING CAP DRIVER Back to Search Results
Model Number 6134.0185
Device Problem Material Fragmentation (1261)
Patient Problem Spinal Column Injury (2081)
Event Type  malfunction  
Manufacturer Narrative
The device was not available as it remains in the patient.It was reported that the creo mis locking cap driver tip sheared off.It cannot be confirmed what step during the procedure the fracture occurred during because surgical conditions cannot be replicated.Because of this, it cannot be determined if the fracture was caused by excessive forces or surgical misuse.No determinations could be made as to the cause of the reported issue.
 
Event Description
It was reported that during a case the tip of the locking cap driver broke off and was retained in the patient post operatively.
 
Manufacturer Narrative
The device was returned for evaluation.It was reported that the creo mis locking cap driver tip sheared and was left in the patient.The deformation to the driver tip past the fracture point is consistent with clockwise torsional forces, meaning the tip was deformed during tightening.This is evidence of excessive force on the driver tip.Because it was not confirmed at what stage of the procedure the locking cap driver was being used for, no determinations could be made as to the cause of the reported issue.
 
Event Description
It was reported that during a case the tip of the locking cap driver broke off and was retained in the patient post operatively.
 
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Brand Name
N/A
Type of Device
LOCKING CAP DRIVER
Manufacturer (Section D)
GLOBUS MEDICAL, INC.
2560 general armistead avenue
audubon PA 19403
Manufacturer (Section G)
GLOBUS MEDICAL, INC.
2560 general armistead avenue
audubon PA 19403
Manufacturer Contact
daniel paul
2560 general armistead avenue
audubon, PA 19403
6109301800
MDR Report Key19043339
MDR Text Key339394441
Report Number3004142400-2024-00062
Device Sequence Number1
Product Code LXH
UDI-Device Identifier00889095178289
UDI-Public00889095178289
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
D154976
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,Followup
Report Date 05/13/2024
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 Number6134.0185
Device Lot NumberEFX093BB
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 03/08/2024
Initial Date FDA Received04/04/2024
Supplement Dates Manufacturer Received03/08/2024
Supplement Dates FDA Received05/14/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/02/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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