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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC AEGIS ANTERIOR LUMBAR PLATE SYSTEM AWL, VARIABLE

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DEPUY SPINE INC AEGIS ANTERIOR LUMBAR PLATE SYSTEM AWL, VARIABLE Back to Search Results
Catalog Number UNK PLATES
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

Product complaint # (b)(4). This report is for an unknown plates/unknown lot number. Without the specific part number, the udi number and 510k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. J&j reporter. (b)(4). Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. Investigation summary product was not returned. Based on the information available, it has been determined that no corrective and preventive action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).

 
Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for patients implanted with depuy synthes aegis¿ anterior lumbar plate for anterior lumbar interbody fusion procedures. Failed anterior lumbar interbody fusion has been identified as the reported complication as per icd 9 & 10 categorization experienced by the following with corresponding intervention: 8 patients had a new surgical reoperation procedure within 24 months following the index anterior lumbar interbody fusion for fusion or device removal within the lumbar spine. 1 patient had subsequent surgery for a new surgical procedure within 90 days following the index anterior lumbar interbody fusion for non-fusion surgeries (excluding device removal) in any region of the lumbar or thoracic spine. This is for aegis anterior lumbar plate eu-mdr study. This report is for one (1) unknown plate/aegis anterior lumbar plate system. This report is 7 of 9 for (b)(4).

 
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Brand NameAEGIS ANTERIOR LUMBAR PLATE SYSTEM
Type of DeviceAWL, VARIABLE
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key9419388
MDR Text Key185261817
Report Number1526439-2019-52610
Device Sequence Number1
Product Code HWJ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,STUDY
Reporter Occupation
Type of Report Initial
Report Date 11/12/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/05/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK PLATES
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/12/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 12/05/2019 Patient Sequence Number: 1
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