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

Catalog Number ROXR05

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Additional qc testing of reserve samples is on-going.

Event Description

It was reported that a patient developed a supracrestal abscess after the implantation procedure to increase the buccal-lingual volume and thickness of the buccal bone plate.The supracrestal tissue was cut away, sutures were placed and the patient was prescribed antibiotics.The patient was determined to be stable.

Event Description

It was reported that a patient developed a supracrestal abscess after the implantation procedure to increase the buccal-lingual volume and thickeness of the buccal bone plate.The supracrestal tissue was cut away, sutures were placed and the patient was prescribed antibiotics.The patient was determined to be stable.

Manufacturer Narrative

Additional qc testing of reserve samples confirmed that the product met acceptance criteria.

• Brand Name: REGENEROSS RESORBABLE XENOGRAFT
• Type of Device: PORCINE ANORGANIC BONE MINERAL
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• MDR Report Key: 9208308
• MDR Text Key: 162867651
• Report Number: 2249852-2019-00020
• Device Sequence Number: 1
• Product Code: NPM
• 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,health profession
• Type of Report: Initial,Followup
• Report Date: 10/25/2019

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: 09/30/2020
• Device Catalogue Number: ROXR05
• Device Lot Number: PMCU17K2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other