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

Catalog Number	OG2030
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional qc testing of reserve samples found the product to be conforming and met release criteria.
Event or Problem Description
The customer claimed that the membrane tore during handling.The clinician was able to complete the procedure using another membrane.There were no significant delays or adverse events reported associated with this event.

• Brand Name: OSSEOGUARD
• Common Device Name: COLLAGEN DENTAL MEMBRANE III
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• MDR Report Key: 9512434
• Report Number: 2249852-2019-00025
• Device Sequence Number: 388950
• Product Code: NPL
• UDI-Device Identifier: 00813954020334
• UDI-Public: 00813954020334
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K062846
• 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): 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: OG2030
• Device Lot Number: CM3N18K5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 12/23/2019
• 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