MAUDE Adverse Event Report: ARTOSS GMBH NANOBONE SBX PUTTY; BONE VOID FILLER

Model Number	200046
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Hematoma (1884); Post Operative Wound Infection (2446)
Date of Event	01/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
This emdr was originally submitted in july 2020 with follow-up in september 2020.It was later discovered that those reports apparently did not upload correctly.Accordingly, they are being consolidated and submitted again here to make sure the reported information is in the emdr system as required.Specifically: patient received nanobone sbx putty in the posterolateral intertransverse process space for single level spinal fusion.At first follow-up visit, patient exhibited migration of a portion of the graft to beneath the skin over the fusion site on radiographs.Patient also exhibited post-operative edema and experienced pain at the surgical site.At three-week follow-up visit, the surgical incision was reopened, hematoma was drained, and incision was washed out.There appeared to be granules of nanobone sbx putty in the hematoma.Specimen taken from surgery site showed infection, organism not identified.The incision was then closed, and edema and pain resolved.Patient went on to successful fusion.

• Brand Name: NANOBONE SBX PUTTY
• Common Device Name: BONE VOID FILLER
• Manufacturer (Section D): ARTOSS GMBH; fischerweg 421; rostock, 18069 ; GM 18069
• MDR Report Key: 17689705
• Report Number: 3011484392-2020-00001
• Device Sequence Number: 6434839
• Product Code: MQV
• UDI-Device Identifier: 14260418440468
• UDI-Public: (01)14260418440468(10)004734(17)220521
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 07/29/2020
• Report Date (Section F): 07/29/2020

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: Health Professional
• Device Expiration Date: 05/22/2022
• Device Model Number: 200046
• Device Catalogue Number: 200046
• Device Lot Number: 004734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/02/2020
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2023
• 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: INTRBDY FUSION CAGE, BONE GRFT, PED. SCREWS PLATES.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 07/29/2020