MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE Y CONTOUR; PELVIC ORGAN PROLAPSE SURGICAL MESH, SYNTHETIC POLYMER

Catalog Number	501520
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Prolapse (2475)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed in veeva to be associated.The device was not returned for evaluation.Without the benefit of analyzing the device, coloplast cannot comment on the condition of the device.Should additional information prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.
Event or Problem Description
According to the available information, the patient underwent a hysterectomy and robotic sacrocolpopexy successfully with restorelle.Approximately 7 weeks post op, the patient felt a "pop" and subsequently lost the vaginal apical support she'd had post surgery.A revision surgery was performed and upon inspection the restorelle y contour was no longer holding up the vaginal cuff to the sacral promontory and appeared to be disconnected somewhere between the sacrum and the vaginal apex.Mesh and sutures could be seen at the promontory and the posterior aspect of the vagina up to the vaginal cuff.No mesh was seen on the anterior vaginal well but that could have been the dissection plane used by the surgeon on the anterior side.The mesh posteriorly was well incorporated into healthy vaginal tissue and only approximately ½ of the mesh was dissected out.A new restorelle mesh was implanted in the patient successfully.The posterior arm was implanted over the previously implanted and incorporated posterior arm while the anterior arm was sewn on with individual sutures and pulled up to the sacrum in the normal manner and fixated with 2 permanent "prolene" sutures.

• Brand Name: RESTORELLE Y CONTOUR
• Common Device Name: PELVIC ORGAN PROLAPSE SURGICAL MESH, SYNTHETIC POLYMER
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 22299530
• Report Number: 2125050-2025-01011
• Device Sequence Number: 21151002
• Product Code: OTO
• UDI-Device Identifier: 05708932528108
• UDI-Public: 05708932528108
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K123914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 501520
• Device Lot Number: 9846241_5015202400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female