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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CONCORD FORTRESS RADIOPAQUE BONE CEMENT, 20G

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GLOBUS MEDICAL, INC. CONCORD FORTRESS RADIOPAQUE BONE CEMENT, 20G Back to Search Results
Model Number 4129.2000S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 03/04/2020
Event Type  malfunction  
Manufacturer Narrative
The product was not available for evaluation as it remains in the patient. Review of the manufacturing records found no deviations or abnormalities. Improper handling of sterile product or surgical instruments during surgery could have contributed to the infection. However, an exact cause of the reported issue could not be determined.
 
Event Description
It was reported that approximately two weeks post-operatively the patient developed an infection within their bone at the site of the surgery.
 
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Brand NameCONCORD
Type of DeviceFORTRESS RADIOPAQUE BONE CEMENT, 20G
Manufacturer (Section D)
GLOBUS MEDICAL, INC.
2560 general armistead avenue
audubon,
Manufacturer (Section G)
GLOBUS MEDICAL, INC.
2560 general armistead avenue
audubon,
Manufacturer Contact
daniel paul
2560 general armistead avenue
audubon, 
9301800
MDR Report Key9973621
MDR Text Key207887932
Report Number3004142400-2020-00032
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042168
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 04/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4129.2000S
Device Lot NumberGBW016PJ
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/17/2020 Patient Sequence Number: 1
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