MAUDE Adverse Event Report: TEPHA, INC. - 3005670760 GALAFLEX LITE; ABSORBABLE MESH

Catalog Number	GFLT0017
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient underwent breast repair procedure with one piece of the galaflex lite 17 cm, cut it in half and used those pieces to secure the implants on (b)(6) 2024.It was reported that the cut pieces likely were not large enough to properly support the 350cc implants.It was also reported that the scaffold was secured to the chest wall, but the implants have migrated together, and so the patient will require revision surgery to correct the situation with galaflex again.
Additional Manufacturer Narrative
As reported, one galaflex lite 17cm was cut into two and used for securing breast implants which have migrated together after breast procedure.Based on the information provided the reported event is determined to be use related.The first-time user of the product cut the mesh into two pieces which were not large enough to properly support the 350cc implants.Review of manufacturing records confirms product was manufactured to specification.Per the instructions-for-use, supplied with this device, "galaflex scaffold may be cut to the shape or size desired for each specific application.The scaffold is to be positioned so its edges extend beyond the margins of the defect.It is recommended that surgical fixation be placed ¼ to ½ inches (6 to 12mm) apart at a distance approximately ¼ inch (6mm) from the edge of the scaffold.The edges are then fixated to assure proper closure under correct tension.When anchoring the scaffold, use the type of suture that is appropriate for your application.The edges or corners of the scaffold should be fixated with suture such that it lies flat against the tissue of the repair site.The scaffold should be sufficiently anchored without the expectation of stretch, to stabilize it during tissue ingrowth." 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 LITE
• Common Device Name: 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: 20133720
• Report Number: 1213643-2024-00435
• Device Sequence Number: 7350641
• Product Code: OOD
• UDI-Device Identifier: 00810054980629
• UDI-Public: (01)00810054980629(17)241031(10)LXGZ0005
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K113721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2024

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 Expiration Date: 10/31/2024
• Device Catalogue Number: GFLT0017
• Device Lot Number: LXGZ0005
• 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: 08/13/2024
• Initial Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2023
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 64 KG