MAUDE Adverse Event Report: ARTOSS GMBH NANOBONE SBX PUTTY; BONE VOID FILLER, PRODUCT CODE: MQV

Model Number	200046
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was operated on for one level posterior cervical spinal fusion.Patient experienced excessive wound drainage at surgery site.At two week follow-up visit, incision was reopened and some nanobone bone graft appeared to have migrated from the implantation site to beneath the skin.Specimen taken from surgery site showed infection, organism not identified.Incision was washed out, then closed and wound drainage resolved.
Additional Manufacturer Narrative
This report was originally submitted on aug 06, 2020 with mfr report number 3011483489-2020-00004 with a subsequent addendum on september 3, 2020.It was discovered that the original submission nor the supplement successfully made it through the electronic checks of the emdr system.The submission combined with its supplemental information is being resubmitted.A capa has been opened to address the submission of the electronic files.

• Brand Name: NANOBONE SBX PUTTY
• Common Device Name: BONE VOID FILLER, PRODUCT CODE: MQV
• Manufacturer (Section D): ARTOSS GMBH; fischerweg 421; rostock, 18069 ; GM 18069
• Manufacturer (Section G): ARTOSS GMBH; fischerweg 421; rostock, 18069 ; GM 18069
• Manufacturer Contact: walter gerike ; fischerweg 421; rostock, 18069 ; GM 18069
• MDR Report Key: 16528055
• Report Number: 3011483489-2020-00003
• Device Sequence Number: 5259498
• Product Code: MQV
• UDI-Device Identifier: 14260418440468
• UDI-Public: (01)14260418440468(10)004734(17)220521
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K190110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2020

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: 05/21/2022
• Device Model Number: 200046
• Device Lot Number: 004734
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American