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

Catalog Number	OSCRM1520
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Additional Manufacturer Narrative
Investigation could not be completed.Collagen matrix, inc.Could not obtain the product lot number and/or expiration date, therefore further assessment could not be performed.
Event or Problem Description
Clinician observed a foreign body reaction with the use of the membrane.The clinician thought it was caused by the membrane but also mentioned patient born and surgically born issues may have led to what was observed.Complaint states that the patient was not injured.

• Brand Name: OSTEOSHIELD
• Common Device Name: COLLAGEN DENTAL MEMBRANE
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• MDR Report Key: 6153397
• Report Number: 2249852-2016-00016
• Device Sequence Number: 19039749
• Product Code: NPL
• UDI-Device Identifier: D716OSCRM15201
• UDI-Public: D716OSCRM15201
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 12/07/2016

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: Dentist
• Device Catalogue Number: OSCRM1520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2016
• Initial Report FDA Received Date: 12/07/2016
• 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