MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. NUOSS CANCELLOUS; BONE GRAFTING MATERIAL

Model Number	509 9002
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional testing performed on the reserve product samples confirms that the product meets acceptance criteria.
Event or Problem Description
The clinician reported that there was no bone integration following the bone graft procedure.A follow-up procedure was performed to remove the product and re-graft the site with another bone graft product which resulted in a 4-6 month delay in implant placement.

• Brand Name: NUOSS CANCELLOUS
• Common Device Name: BONE GRAFTING MATERIAL
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• MDR Report Key: 7834346
• Report Number: 2249852-2018-00011
• Device Sequence Number: 16535354
• Product Code: NPM
• UDI-Device Identifier: 00614950007431
• UDI-Public: 00614950007431
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 08/29/2018

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: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: 509 9002
• Device Lot Number: BM2CU16A1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/30/2018
• 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