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

Catalog Number	501520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Osteomyelitis (4533)
Date of Event	12/31/2024
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 to be associated.The device was not returned for evaluation.Without the benefit of analyzing the device, quality 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
As reported to coloplast, though not verified: the patient had a restorelle implanted in (b)(6) 2024.Reportedly the patient experienced right hip, back, and buttock pain.In (b)(6) 2025, patient presented to the emergency department and was admitted for infection of sacrocolpopexy mesh (restorelle y) at attachment anterior l5-s1 with secondary discitis-osteomyelitis.Patient underwent robotic assisted mesh excision and drainage of retroperitoneal collection under general anesthesia.The patient was discharged from hospital on iv antibiotics.Patient readmitted for continued back pain.Received pain medication and muscle relaxers and ultimately underwent l4-l5 posterior arthrodesis, l5-s1 posterior arthrodesis, segmental instrumentation l4-s1 using alphatec invictus, attachment of caudal instrumentation to the pelvis using s2 ai screws alphatec and use of local autograft and allograft supplemented with bmp under general anesthesia.

• 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 (Section G): MINNEAPOLIS
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 24108935
• Report Number: 2125050-2026-00089
• Device Sequence Number: 14906935
• Product Code: OTO
• UDI-Device Identifier: 05708932528108
• UDI-Public: 5708932528108
• Combination Product (Y/N): N
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/19/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 501520
• Device Lot Number: 9846241_5015202400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/19/2026
• 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: Disability; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Unknown