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

Catalog Number ROXR05

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

Patient Problem Inadequate Osseointegration (2646)

Event Date 04/27/2019

Event Type  Injury  

Event Description

It was reported that a clinician used the porcine xenograft along with puros particulate allograft and a biomend absorbale collagen membrane.The patient returned after 5 months for implant placement.The clinician reported to be unhappy with the outcome of the bone augmentation and the implant was unable to be placed.

• Brand Name: REGENEROSS RESORBABLE XENOGRAFT
• 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: 9208314
• MDR Text Key: 163124858
• Report Number: 2249852-2019-00021
• Device Sequence Number: 1
• Product Code: NPM
• UDI-Device Identifier: 00813954022338
• UDI-Public: 00813954022338
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: ROXR05
• Device Lot Number: PMCU18C4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2017
• 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
• Patient Outcome(s): Other