MAUDE Adverse Event Report: ACELL, INC. GENTRIX SURGICAL MATRIX PLUS

Model Number	MSPL0507
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	12/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being submitted due to the reported obstruction that occurred after the initial placement of the acell device.The acell device was explanted; however it is not available for evaluation.A review of the manufacturing records for this lot identified no deviations in the production process that fall outside of specification.The device was manufactured and distributed sterile in compliance with acell's operating procedures and federal, state, and local laws and regulations.We are submitting this report now, however, additional information has been requested.An update "wlll" be provided upon "reciept" of more information.
Event or Problem Description
On 12/6/19, acell, inc.Became aware that an acell device was explanted due to a bowel obstruction.The acell device was implanted (b)(6) 2019 and explanted on (b)(6) 2019.We are submitting this report now, however, additional information has been requested.An update "wlll" be provided upon reciept of more information.

• Brand Name: GENTRIX SURGICAL MATRIX PLUS
• Common Device Name: GENTRIX SURGICAL MATRIX PLUS
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney dr.; columbia MD 21046
• MDR Report Key: 9538229
• Report Number: 3005920706-2019-00023
• Device Sequence Number: 2334442
• Product Code: FTM
• UDI-Device Identifier: 00386190001226
• UDI-Public: (01)00386190001226(17)201130(10)014594
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K182259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2019

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: 11/30/2020
• Device Model Number: MSPL0507
• Device Catalogue Number: MSPL0507
• Device Lot Number: 014594
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention