MAUDE Adverse Event Report: PMT CORPORATION INTEGRA TISSUE EXPANDER

Model Number	3610-06-2I
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: visual inspection of video provided by the customer and documentation review was conducted.In the video provided by the customer, there is no evidence of the doctor using the port locator nor marking the location of the internal port on the patient's skin.It is likely that the needle punctured the shell of the expander rather than the internal port.Conclusion: the internal port was not appropriately located by the doctor and when attempting to fill punctured the shell of the tissue expander causing it to leak.
Event or Problem Description
Customer has sent photos and videos of a pediatric patient with this expander implanted for an ear reconstruction case.Videos show expander being filled, and once needle is removed, saline immediately sprays out of the entry point through the patient's skin.No expansion is happening because of this.

• Brand Name: INTEGRA TISSUE EXPANDER
• Common Device Name: TISSUE EXPANDER
• Manufacturer (Section D): PMT CORPORATION; 1500 park road; chanhassen MN 55317
• Manufacturer (Section G): PMT CORPORATION; 1500 park road; chanhassen MN 55317
• Manufacturer Contact: kim schmelzer ; 1500 park road; chanhassen, MN 55317 ; 9524700866
• MDR Report Key: 21093300
• Report Number: 2182979-2025-00001
• Device Sequence Number: 9171840
• Product Code: LCJ
• UDI-Device Identifier: 00650551029069
• UDI-Public: 00650551029069
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K845036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2025

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 Expiration Date: 07/28/2026
• Device Model Number: 3610-06-2I
• Device Catalogue Number: 3610-06-2I
• Device Lot Number: 072822
• 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: 12/04/2024
• Initial Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown