MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. SYMBIOS XENOGRAFT GRANULES; PORCINE ANORGANIC BONE MINERAL

Catalog Number 32310001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fibrosis (3167)

Event Type  Injury  

Event Description

Report of exuberant growth of bulbous, fibrous mass over the extraction site was received, the mass was excised and submitted for histopathological evaluation by the clinician.Collagen matrix, inc.Has not received the evaluation results from the reporting clinician.The product was left in place and the patient was doing well at the time of reporting.

• Brand Name: SYMBIOS XENOGRAFT GRANULES
• Type of Device: PORCINE ANORGANIC BONE MINERAL
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• Manufacturer (Section G): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• Manufacturer Contact: gloria zuclich ; 15 thornton road; oakland, NJ 07436 ; 2014051477
• MDR Report Key: 6227247
• MDR Text Key: 64019796
• Report Number: 2249852-2017-00001
• Device Sequence Number: 1
• Product Code: NPM
• UDI-Device Identifier: M440323100010
• UDI-Public: M440323100010
• Combination Product (y/n): N
• PMA/PMN Number: K140714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 32310001
• Device Lot Number: PMCU15H3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 4-0 CHROMIC GUT SUTURES; ORAPLUG
• Patient Outcome(s): Other