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

Model Number	100042-05
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Ptosis (2620)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient was implanted with galaflex 3d during an implant exchange procedure.The implant in the left breast has shifted laterally and inferiorly.Based on the information provided the degree to which the galaflex 3d implant used to treat the patient, may have caused or contributed to the patient's postoperative course is unknown.A review of manufacturing records was conducted and shows the product was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units.Note, the date of event (23-oct-2025) is considered to be the best estimate.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, the patient was implanted with galaflex 3d during an implant exchange procedure.It was reported that 5 months post implantation the implant in the left breast has shifted laterally and inferiorly.The surgeon is planning to replace the galaflex with another version and to perform additional internal tightening to reposition the implant.

• Brand Name: GALAFLEX 3D
• 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: 23533791
• Report Number: 1213643-2025-01090
• Device Sequence Number: 9020977
• Product Code: OOD
• UDI-Device Identifier: 00810054980308
• UDI-Public: (01)00810054980308(17)270622(10)LXHW0009
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K161092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/29/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 100042-05
• Device Catalogue Number: SH3D05
• Device Lot Number: LXHW0009
• 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: 10/23/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2024
• 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: Other
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 60 KG