MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. MEM-LOK; COLLAGEN DENTAL MEMBRANE

Catalog Number	RCM-ML3040
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As indicated in the instructions for use, infection is a known inherent risk associated with any surgical procedure.Reserve sample testing confirmed that the product met release criteria.
Event or Problem Description
The clinician reported that 10 days following initial dental procedure a surgical site infection was observed and required follow-up procedure to remove the membrane.Upon re-entry of the surgical site the clinician observed that the membrane was "gone".Primary closure was attained and sutures were intact prior to follow-up procedure.

• Brand Name: MEM-LOK
• Common Device Name: COLLAGEN DENTAL MEMBRANE
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• MDR Report Key: 7847186
• Report Number: 2249852-2018-00012
• Device Sequence Number: 16478270
• Product Code: NPL
• UDI-Device Identifier: 00813954020761
• UDI-Public: 00813954020761
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K003339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/05/2018

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: 09/30/2020
• Device Catalogue Number: RCM-ML3040
• Device Lot Number: CMN17L2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 09/05/2018
• 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