MAUDE Adverse Event Report: RTI SURGICAL NANOSS 3D, ADVANCED BONE GRAFT SUBSTITUTE, 25MM(W)X100MM(L) X8MM(H), 20CC; FILLER, BONE VOID, CALCIUM COMPOUND

Model Number	90-300-251008
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Post Operative Wound Infection (2446)
Date of Event	03/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the initial reporter, it is unlikely that the rti surgical device caused this infection.The dhr was reviewed and the device was manufactured to specifications.Device not returned.
Event or Problem Description
On (b)(6) 2016 the patient underwent a spinal fusion.Then during a follow up visit on (b)(6) 2016, the patient showed symptoms of a possible infection.The patient was experiencing back and leg pain as well.The next day, the patient underwent incision and drainage and graft removal as well as the removal of the nanoss 3d product.Then on (b)(6) 2016,the patient underwent a second incision and drainage process with graft replacement with bmp.

• Brand Name: NANOSS 3D, ADVANCED BONE GRAFT SUBSTITUTE, 25MM(W)X100MM(L) X8MM(H), 20CC
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): RTI SURGICAL; 375 river park circle; marquette MI 49855
• MDR Report Key: 5548955
• Report Number: 1833824-2016-00015
• Device Sequence Number: 894986
• Product Code: MQV
• UDI-Device Identifier: 00846468049577
• UDI-Public: (01)00846468049577(17)161130(10)209477
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K132050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/05/2016

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: Physician
• Device Expiration Date: 11/30/2016
• Device Model Number: 90-300-251008
• Device Catalogue Number: SAME
• Device Lot Number: 209477
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2016
• Initial Report FDA Received Date: 04/05/2016
• 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: Required Intervention
• Patient Age: 51 YR