Allergan did not submit this mdr within 30 days of becoming aware. Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume. Allergan is implementing a plan to address the increased volumes. A review of the device history record has been completed. No deviations or non-conformances noted. Device evaluation: visual analysis of the returned device identified: underweight, broken shell, crease flat and missing piece of the shell. A microscopic analysis was performed which identify sharp edge broken assessed as unidentified tear broken. A dimension measurement in the shell was performed which identify the thickness within specification. Based on the device analysis the final assessment is: a sharp broken on posterior side due to an unidentified (tear) opening; missing piece of the shell due to inconclusive. Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. Reason for reoperation: rupture.
Patient Sequence No: 1, Text Type: N, H10
Physician has reported "implant rupture". Device has been explanted. This relates to the right side.
Patient Sequence No: 1, Text Type: D, B5