NanoBone® SBX Putty 200046Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 14260418440468), received between Mar 7, 2023 and Sep 6, 2023 — classified as 12 injuries.

The most frequently reported specific device problem is “Migration” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2023Migration; Migration

  THIS EMDR WAS ORIGINALLY SUBMITTED IN AUGUST 2020 WITH A FOLLOW-UP IN SEPTEMBER 2020. IT WAS LATER DISCOVERED THAT THOSE REPORTS APPARENTLY DID NOT UPLOAD INTO FDA'S EMDR SYSTEM CORRECTLY. ACCORDINGLY, THEY ARE BEING CONSOLIDATED AND SUBMITTED AGAIN HERE TO MAKE SURE THE REPORTED INFORMATION IS IN THE EMDR SYSTEM AS REQUIRED. SPECIFICALLY: A REPORT OF POSSIBLE MIGRATION OF A PORTION OF THE NANOBONE SBX PUTTY AND /OR INFECTION OF THE SURGICAL SITE WAS RECEIVED FROM A PHYSICIAN'S ASSISTANT. PATIENT WAS OPERATED ON FOR ONE LEVEL LUMBAR SPINAL FUSION. PATIENT EXPERIENCED POST-OPERATIVE EDEMA AND EXCESSIVE 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. INCISION WAS WASHED OUT, THEN CLOSED AND DRAINAGE AND EDEMA RESOLVED.

  Patient problems: Hematoma

  MAUDE report 17695622 ↗
• InjurySep 6, 2023Migration; Migration

  THIS EMDR WAS ORIGINALLY SUBMITTED IN AUGUST 2020 WITH A FOLLOW-UP IN SEPTEMBER 2020. IT WAS LATER DISCOVERED THAT THOSE REPORTS APPARENTLY DID NOT UPLOAD INTO FDA'S EMDR SYSTEM CORRECTLY. ACCORDINGLY, THEY ARE BEING CONSOLIDATED AND SUBMITTED AGAIN HERE TO MAKE SURE THE REPORTED INFORMATION IS IN THE EMDR SYSTEM AS REQUIRED. SPECIFICALLY: A REPORT OF POSSIBLE MIGRATION OF A PORTION OF THE NANOBONE SBX PUTTY AND /OR INFECTION OF THE SURGICAL SITE WAS RECEIVED FROM A PHYSICIAN'S ASSISTANT. PATIENT WAS OPERATED ON FOR ONE LEVEL LUMBAR SPINAL FUSION. PATIENT EXPERIENCED EXCESSIVE POST-OP EDEMA AND PAIN 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. INCISION WAS WASHED OUT, THEN CLOSED AND EDEMA AND PAIN RESOLVED.

  Patient problems: Hematoma

  MAUDE report 17695597 ↗
• InjurySep 6, 2023Migration; Migration

  THIS EMDR ALONG WITH A FOLLOW-UP WERE ORIGINALLY SUBMITTED IN AUGUST 2020. IT WAS LATER DISCOVERED THAT THOSE REPORTS APPARENTLY DID NOT UPLOAD INTO FDA'S EMDR SYSTEM CORRECTLY. ACCORDINGLY, THEY ARE BEING CONSOLIDATED AND SUBMITTED AGAIN HERE TO MAKE SURE THE REPORTED INFORMATION IS IN THE EMDR SYSTEM AS REQUIRED. SPECIFICALLY: A REPORT OF POSSIBLE MIGRATION OF A PORTION OF THE NANOBONE SBX PUTTY AND /OR INFECTION OF THE SURGICAL SITE WAS RECEIVED FROM A PHYSICIAN'S ASSISTANT. 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. THIS WAS SUPPORTED BY RADIOGRAPHS AND PHOTOGRAPHS OF THE OPENED INCISION. SPECIMEN TAKEN FROM SURGERY SITE SHOWED INFECTION, ORGANISM NOT IDENTIFIED. INCISION WAS WASHED OUT, THEN CLOSED AND WOUND DRAINAGE RESOLVED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 17695462 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  THIS EMDR WAS ORIGINALLY SUBMITTED IN AUGUST 2020 WITH FOLLOW-UP IN SEPTEMBER 2020. IT WAS LATER DISCOVERED THAT THOSE REPORTS APPARENTLY DID NOT UPLOAD INTO FDA'S EMDR SYSTEM CORRECTLY. ACCORDINGLY, THEY ARE BEING CONSOLIDATED AND SUBMITTED AGAIN HERE TO MAKE SURE THE REPORTED INFORMATION IS IN THE EMDR SYSTEM AS REQUIRED. SPECIFICALLY: A REPORT OF POSSIBLE MIGRATION OF A PORTION OF THE NANOBONE SBX PUTTY AND /OR INFECTION OF THE SURGICAL SITE WAS RECEIVED FROM A PHYSICIAN'S ASSISTANT FOR AN UNKNOWN SURGICAL PROCEDURE/SURGICAL INTERVENTION. 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.

  Patient problems: Post Operative Wound Infection

  MAUDE report 17690646 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  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 INTO FDA'S EMDR SYSTEM CORRECTLY. ACCORDINGLY, THEY ARE BEING CONSOLIDATED AND SUBMITTED AGAIN HERE TO MAKE SURE THE REPORTED INFORMATION IS IN THE EMDR SYSTEM AS REQUIRED. SPECIFICALLY: A REPORT OF POSSIBLE MIGRATION OF A PORTION OF THE NANOBONE SBX PUTTY AND/OR INFECTION OF THE SURGICAL SITE WAS RECEIVED BUT DETAILS OF THE EVENT WERE NOT PROVIDED. IT WAS LATER LEARNED THAT THE PATIENT WAS OPERATED ON FOR THREE-LEVEL POSTERIOR CERVICAL SPINAL FUSION, AND THAT THE PATIENT EXPERIENCED POST-OPERATIVE EDEMA AND PAIN AT SURGERY SITE. AT THE FIVE-WEEK FOLLOW-UP VISIT, THE INCISION WAS REOPENED AND WASHED OUT. ADDITIONAL BONE GRAFT WAS PLACED. THE INCISION WAS CLOSED AND THE EDEMA AND PAIN RESOLVED.

  Patient problems: Hematoma

  MAUDE report 17689716 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  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.

  Patient problems: Hematoma; Post Operative Wound Infection

  MAUDE report 17689705 ↗
• InjuryMar 13, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  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.

  Patient problems: Pain

  MAUDE report 16528055 ↗
• InjuryMar 13, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  PATIENT WAS OPERATED ON FOR ONE LEVEL LUMBAR SPINAL FUSION. PATIENT EXPERIENCED POST-OPERATIVE EDEMA AND EXCESSIVE 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. INCISION WAS WASHED OUT, THEN CLOSED AND DRAINAGE AND EDEMA RESOLVED.

  Patient problems: Pain

  MAUDE report 16528000 ↗
• InjuryMar 13, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  PATIENT WAS OPERATED ON FOR ONE LEVEL LUMBAR SPINAL FUSION. PATIENT EXPERIENCED EXCESSIVE POST-OP EDEMA AND PAIN 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. INCISION WAS WASHED OUT, THEN CLOSED AND EDEMA AND PAIN RESOLVED.

  Patient problems: Pain

  MAUDE report 16527990 ↗
• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS OPERATED ON FOR THREE LEVEL POSTERIOR CERVICAL SPINAL FUSION. PATIENT EXPERIENCED POST-OPERATIVE EDEMA AND PAIN AT SURGERY SITE. AT FIVE WEEK FOLLOW-UP VISIT, INCISION WAS REOPENED AND WASHED OUT. ADDITIONAL BONE GRAFT WAS PLACED. INCISION WAS CLOSED AND EDEMA AND PAIN RESOLVED.

  Patient problems: Pain

  MAUDE report 16527931 ↗
• InjuryMar 7, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  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.

  Patient problems: Pain

  MAUDE report 16494912 ↗
• InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS OPERATED ON FOR SINGLE LEVEL LUMBAR SPINAL FUSION. PATIENT EXPERIENCED POST-OPERATIVE EDEMA AND PAIN AT SURGERY SITE. AT THREE WEEK FOLLOW-UP VISIT, INCISION WAS REOPENED AND WASHED OUT. SPECIMEN TAKEN FROM SURGERY SITE SHOWED INFECTION, ORGANISM NOT IDENTIFIED. INCISION WAS CLOSED AND EDEMA AND PAIN RESOLVED. PATIENT WENT ON TO SUCCESSFUL FUSION.

  Patient problems: Iritis

  MAUDE report 16494784 ↗