MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. NUOSS CORTICAL; OSTEOGUIDE ANORGANIC BONE MINERAL

Catalog Number	5091004
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Inflammation (1932); Inadequate Osseointegration (2646)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional qc testing of the reserve samples confirmed that the product is conforming and met acceptance criteria.There are no indications that the product would not perform as designed.
Event or Problem Description
The doctor stated that after noticing the bone quality was not what the doctor was used to seeing, the patient returned back to the office where the nuoss fell out of its graft site.Subsequent to the request for additional feedback, the clinician stated that following ridge preservation procedure an unspecified emergency event occurred during the healing process.At the time loose, unincorporated nuoss particles were found in the site.Additionally, the patient presented with unresolved submandibular gland lymphadenopathy and floor of mouth swelling and was refered to ent physician.

• Brand Name: NUOSS CORTICAL
• Common Device Name: OSTEOGUIDE ANORGANIC BONE MINERAL
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• MDR Report Key: 7178437
• Report Number: 2249852-2018-00005
• Device Sequence Number: 1090468
• Product Code: NPM
• UDI-Device Identifier: 00614950007271
• UDI-Public: 00614950007271
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K043034
• 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): 01/09/2018

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?: Yes
• Operator of Device: Dentist
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 5091004
• Device Lot Number: BMTU15N2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED COLLAGEN DENTAL MEMBRANE
• Outcome Attributed to Adverse Event: Other