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

Model Number 200046

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 311132779
• Report Number: 3011483489-2020-00003
• Device Sequence Number: 1
• Product Code: MQV
• UDI-Device Identifier: 14260418440468
• UDI-Public: (01)14260418440468(10)004734(17)220521
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2022
• Device Model Number: 200046
• Device Lot Number: 004734
• Date Manufacturer Received: 09/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American