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

Model Number	100043-02
Medical Device Problem Codes	Material Deformation (2976); Migration (4003)
Health Effect - Clinical Code	Physical Asymmetry (4573)
Date of Event	12/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported during a procedure on (b)(6) 2025, a galaflex 3dr implant was implanted, post implant the implant did not perform as intended, resulting in the need for a revision surgery on (b)(6) 2025, in which another sheet of galaflex implant was used.According to the report, the implant appeared to be folded and shriveled, and follow-up evaluations indicated that the left implant appeared to be dropping.
Additional Manufacturer Narrative
As reported, post implant the galaflex 3dr did not establish as intended, and the implant was folded, shriveled and the patient felt like the left implant was dropping, required revision surgery to implant another galaflex implant.The photos provided shows the explanted galaflex mesh.However, based on the photos and information provided, the degree to which the galaflex 3dr 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.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 during a procedure on (b)(6) 2025, a galaflex 3dr implant was implanted, post implant the implant did not perform as intended, resulting in the need for a revision surgery on (b)(6) 2025, in which another sheet of galaflex implant was used.According to the report, the implant appeared to be folded and shriveled, and follow-up evaluations indicated that the left implant appeared to be dropping.Addendum per additional information provided: a 39-year-old female patient had history of bilateral breast augmentation with implant malposition thereby underwent bilateral breast implant exchange, placement of allergan scf 520cc silicone gel implants, placement of galaflex 3dr mesh bilaterally, bilateral lateral thermal capsulorrhaphy and excision of previous inframammary scars on (b)(6) 2025.Per op notes, ¿the previous inframammary incisions were excised to remove prior scar tissue.The implants were removed intact bilaterally, the explanted implants were identified as mentor 500cc moderate plus profile silicone gel.Lateral thermal capsulorrhaphy was then performed bilaterally to address lateral implant malposition.Galaflex 3dr mesh was placed along the inferior and lateral pocket margins bilaterally, it was secured using sutures to the chest wall and surrounding capsule to provide additional support and stability to the implant pocket.New allergan scf 520cc silicone gel implants were inserted.¿ on (b)(6) 2025, patient had left breast implant malposition with inferior pocket stretch and loss of lower pole support thereby underwent repair with removal and replacement of left galaflex 3dr mesh and left inferior capsulorrhaphy.Per op notes, ¿the previous left inframammary incision was opened and dissected down.The previously placed galaflex 3dr mesh was identified along the lower pole and was not incorporated into the tissues; this was carefully dissected free from the surrounding capsule and soft tissue and removed and the mesh appeared lax.The capsulorrhaphy was then performed.A new galaflex 3d mesh was then placed along the inferior pole of the left breast pocket to the capsulorrhaphy repair and secured to the chest wall capsule and soft tissue using sutures.¿.
Additional Manufacturer Narrative
As reported, post implant the galaflex 3dr did not establish as intended, and the implant was folded, shriveled and the patient felt like the left implant was dropping, required revision surgery to implant another galaflex implant.The photos provided shows the explanted galaflex mesh.However, based on the photos and information provided, the degree to which the galaflex 3dr 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.Addendum: this is an addendum to the initial mdr submitted to document the additional information provided.Based on the additional information provided, the patient had left breast implant malposition with inferior pocket stretch and loss of lower pole support thereby underwent repair with removal and replacement of left galaflex 3dr implant.Based on the information provided, the degree to which the galaflex 3dr implant used to treat the patient, may have caused, or contributed to the patient's postoperative course is unknown.The adverse reactions section of the instructions-for-use supplied with the device list scaffold migration as a possible complication.Updated fields: a2, a4, b4, b5, b7, g3, g6, h2, h6, h10.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.

• 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: 24260143
• Report Number: 1213643-2026-00080
• Device Sequence Number: 21219951
• Product Code: OOD
• UDI-Device Identifier: 00810054980018
• UDI-Public: (01)00810054980018(17)270208(10)LXHW0020
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K162922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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 Model Number: 100043-02
• Device Catalogue Number: FR3D02
• Device Lot Number: LXHW0020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• 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: 39 YR
• Patient Sex: Female
• Patient Weight: 57 KG