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

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 5 of 9 for (b)(4).

• Brand Name: AEGIS ANTERIOR LUMBAR PLATE SYSTEM
• Type of Device: AWL, 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 Key: 9419381
• MDR Text Key: 185268750
• Report Number: 1526439-2019-52602
• Device Sequence Number: 1
• Product Code: HWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Reporter Occupation: Other
• 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 Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK PLATES
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention