MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. BIOMEND; COLLAGEN DENTAL MEMBRANE

Catalog Number	0103Z
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	04/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a clinician used the porcine xenograft along with puros particulate allograft and a biomend absorbable 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: BIOMEND
• Common Device Name: COLLAGEN DENTAL MEMBRANE
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• MDR Report Key: 9208317
• Report Number: 2249852-2019-00022
• Device Sequence Number: 10865088
• Product Code: NPL
• UDI-Device Identifier: 00813954022338
• UDI-Public: 00813954022338
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K062846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2019

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: 09/30/2021
• Device Catalogue Number: 0103Z
• Device Lot Number: CDMA18L1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 10/18/2019
• 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