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

Catalog Number	ROXR40
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); No Code Available (3191)
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reported having adverse events that they have not seen in the past.These adverse events include bone loss, delayed healing and inflammation.It is unknown how the clinician circumvented the issues.

• Brand Name: REGENEROSS RESORBABLE XENOGRAFT
• Common Device Name: PORCINE ANORGANIC BONE MINERAL
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• MDR Report Key: 9106059
• Report Number: 2249852-2019-00018
• Device Sequence Number: 11430286
• Product Code: NPM
• UDI-Device Identifier: 00813954022369
• UDI-Public: 00813954022369
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K140714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2019

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 Catalogue Number: ROXR40
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/23/2019
• 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: Other