MAUDE Adverse Event Report: TEPHA, INC. - 3005670760 GALAFLEX 3DR; BREAST - ABSORBABLE MESH

Model Number	100043-05
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the galaflex 3dr scaffold rim almost came off while folding.Additionally, it was observed that the mesh was less stretchy and felt different.Based on the investigation findings of device 1 from the same lot, the most probable cause may be related to the manufacturing process.Analysis of the returned sample (device 1) identified the mesh rim has become detached/tore from the mesh and was found to be manufacturing related as it does not appear the mesh was properly melted and fused with the rim.However, without the sample to evaluate a definitive cause as to why the rim may have detached from this mesh (device 2) could not be determined.A review of the manufacturing records was performed and found that the lot was manufactured to the specification.This emdr represents the galaflex 3dr (device 2).Additional emdr was submitted to represent the other galaflex 3dr (device 1).Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
As reported on (b)(6) 2026, one piece of galaflex 3dr scaffold was used by the surgeon.While folding, it was observed that the rim almost came off.Due to this, another piece was opened by the surgeon, and the rim came off in few spots, and the surgeon opted to proceed with the implantation with it.Additionally, it was observed that the mesh was less stretchy and felt different.There was no patient harm or injury.

• Brand Name: GALAFLEX 3DR
• Common Device Name: BREAST - ABSORBABLE MESH
• Manufacturer (Section D): TEPHA, INC. - 3005670760; 99 hayden ave suite 360; lexington MA 02421
• Manufacturer (Section G): TEPHA, INC. - 3005670760; 99 hayden ave suite 360; lexington MA 02421
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 25518454
• Report Number: 1213643-2026-00756
• Device Sequence Number: 10164750
• Product Code: OOD
• UDI-Device Identifier: 00810054980049
• UDI-Public: (01)00810054980049(17)290414(10)LXJP0032
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K162922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 100043-05
• Device Catalogue Number: FR3D05
• Device Lot Number: LXJP0032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2026
• Initial Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2025
• 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: Other
• Patient Sex: Female