Gibson Healthcare® Bone Graft Plug 5824-413Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10813954024230), received between Mar 2, 2023 and Jul 22, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS RECEIVED REGARDING A GIBSON HEALTHCARE BONE GRAFT PLUG, STATING THE "ITEM EXPLODED IN THE PATIENT'S MOUTH". ON (B)(6) 2025, A PATIENT UNDERWENT AN EXTRACTION AND GRAFT PROCEDURE ON TOOTH #14. ON (B)(6) 2025, MEDICAL INTERVENTION WAS REQUIRED AND THE CLINICIAN REMOVED THE BONE GRAFT PLUG AND REPLACED WITH A DIFFERENT BONE GRAFT PLUG (OSTEOGEN, NOT A CMI PRODUCT). THERE WAS NO INDICATION OF A SURGICAL DELAY. NO FURTHER INFORMATION REGARDING PATIENT STATUS OR PATIENT OUTCOME WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22568567 ↗
• InjuryMar 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  CUSTOMER INITIALLY REPORTED THE GIBSON BONE GRAFT PLUG WAS CAUSING HEALING ISSUES WITH "A NUMBER OF PATIENTS." ADDITIONAL, LIMITED INFORMATION WAS PROVIDED. CUSTOMER STATED AT LEAST FIVE PATIENTS EXPERIENCED HEALING ISSUES. FOR PATIENT 4 OF 5, THE BONE GRAFT APPEARED TO QUICKLY SWELL, APPEAR INFECTED AND EXTRUDE FROM THE EXTRACTION SITE. A FEW DAYS AFTER IMPLANTATION (IMPLANT DATE NOT PROVIDED), PATIENT RETURNED TO THE OFFICE AND REPORTED HAVING A "TERRIBLE TASTE AND SMELL." MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE GRAFT AND CLEAN THE EXTRACTION SITE. AFTER THE INITIAL INTERVENTION, CUSTOMER REPORTED THAT SOME PATIENTS HAD TO RETURN TO THE OFFICE "A FEW TIMES" TO REMOVE THE GRAFT MATERIAL THAT CONTINUED TO EXTRUDE AND CLEAN AND IRRIGATE THE SITES. IT WAS NOT SPECIFIED HOW MANY PATIENTS HAD TO RETURN TO THE OFFICE, NOR WAS IT SPECIFIED HOW MANY TIMES THE PATIENTS HAD TO RETURN TO THE OFFICE. CUSTOMER STATED THIS CAUSED DELAYED HEALING AND PATIENT PAIN. CUSTOMER CONFIRMED "PATIENTS ARE FINE NOW." HOWEVER, THERE WAS NO INFORMATION PROVIDED ON CURRENT PATIENT STATUS, OTHER SPECIFIC PATIENT INFORMATION, AND OUTCOME OF EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 16469510 ↗
• InjuryMar 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  CUSTOMER INITIALLY REPORTED THE GIBSON BONE GRAFT PLUG WAS CAUSING HEALING ISSUES WITH "A NUMBER OF PATIENTS." ADDITIONAL, LIMITED INFORMATION WAS PROVIDED. CUSTOMER STATED AT LEAST FIVE PATIENTS EXPERIENCED HEALING ISSUES. FOR PATIENT 1 OF 5, THE BONE GRAFT APPEARED TO QUICKLY SWELL, APPEAR INFECTED AND EXTRUDE FROM THE EXTRACTION SITE. A FEW DAYS AFTER IMPLANTATION (IMPLANT DATE NOT PROVIDED), PATIENT RETURNED TO THE OFFICE AND REPORTED HAVING A "TERRIBLE TASTE AND SMELL." MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE GRAFT AND CLEAN THE EXTRACTION SITE. AFTER THE INITIAL INTERVENTION, CUSTOMER REPORTED THAT SOME PATIENTS HAD TO RETURN TO THE OFFICE "A FEW TIMES" TO REMOVE THE GRAFT MATERIAL THAT CONTINUED TO EXTRUDE AND CLEAN AND IRRIGATE THE SITES. IT WAS NOT SPECIFIED HOW MANY PATIENTS HAD TO RETURN TO THE OFFICE, NOR WAS IT SPECIFIED HOW MANY TIMES THE PATIENTS HAD TO RETURN TO THE OFFICE. CUSTOMER STATED THIS CAUSED DELAYED HEALING AND PATIENT PAIN. CUSTOMER CONFIRMED "PATIENTS ARE FINE NOW." HOWEVER, THERE WAS NO INFORMATION PROVIDED ON CURRENT PATIENT STATUS, OTHER SPECIFIC PATIENT INFORMATION, AND OUTCOME OF EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 16467630 ↗
• InjuryMar 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  CUSTOMER INITIALLY REPORTED THE GIBSON BONE GRAFT PLUG WAS CAUSING HEALING ISSUES WITH "A NUMBER OF PATIENTS." ADDITIONAL, LIMITED INFORMATION WAS PROVIDED. CUSTOMER STATED AT LEAST FIVE PATIENTS EXPERIENCED HEALING ISSUES. FOR PATIENT 5 OF 5, THE BONE GRAFT APPEARED TO QUICKLY SWELL, APPEAR INFECTED AND EXTRUDE FROM THE EXTRACTION SITE. A FEW DAYS AFTER IMPLANTATION (IMPLANT DATE NOT PROVIDED), PATIENT RETURNED TO THE OFFICE AND REPORTED HAVING A "TERRIBLE TASTE AND SMELL." MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE GRAFT AND CLEAN THE EXTRACTION SITE. AFTER THE INITIAL INTERVENTION, CUSTOMER REPORTED THAT SOME PATIENTS HAD TO RETURN TO THE OFFICE "A FEW TIMES" TO REMOVE THE GRAFT MATERIAL THAT CONTINUED TO EXTRUDE AND CLEAN AND IRRIGATE THE SITES. IT WAS NOT SPECIFIED HOW MANY PATIENTS HAD TO RETURN TO THE OFFICE, NOR WAS IT SPECIFIED HOW MANY TIMES THE PATIENTS HAD TO RETURN TO THE OFFICE. CUSTOMER STATED THIS CAUSED DELAYED HEALING AND PATIENT PAIN. CUSTOMER CONFIRMED "PATIENTS ARE FINE NOW." HOWEVER, THERE WAS NO INFORMATION PROVIDED ON CURRENT PATIENT STATUS, OTHER SPECIFIC PATIENT INFORMATION, AND OUTCOME OF EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 16467626 ↗
• InjuryMar 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  CUSTOMER INITIALLY REPORTED THE GIBSON BONE GRAFT PLUG WAS CAUSING HEALING ISSUES WITH "A NUMBER OF PATIENTS." ADDITIONAL, LIMITED INFORMATION WAS PROVIDED. CUSTOMER STATED AT LEAST FIVE PATIENTS EXPERIENCED HEALING ISSUES. FOR PATIENT 3 OF 5, THE BONE GRAFT APPEARED TO QUICKLY SWELL, APPEAR INFECTED AND EXTRUDE FROM THE EXTRACTION SITE. A FEW DAYS AFTER IMPLANTATION (IMPLANT DATE NOT PROVIDED), PATIENT RETURNED TO THE OFFICE AND REPORTED HAVING A "TERRIBLE TASTE AND SMELL." MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE GRAFT AND CLEAN THE EXTRACTION SITE. AFTER THE INITIAL INTERVENTION, CUSTOMER REPORTED THAT SOME PATIENTS HAD TO RETURN TO THE OFFICE "A FEW TIMES" TO REMOVE THE GRAFT MATERIAL THAT CONTINUED TO EXTRUDE AND CLEAN AND IRRIGATE THE SITES. IT WAS NOT SPECIFIED HOW MANY PATIENTS HAD TO RETURN TO THE OFFICE, NOR WAS IT SPECIFIED HOW MANY TIMES THE PATIENTS HAD TO RETURN TO THE OFFICE. CUSTOMER STATED THIS CAUSED DELAYED HEALING AND PATIENT PAIN. CUSTOMER CONFIRMED "PATIENTS ARE FINE NOW." HOWEVER, THERE WAS NO INFORMATION PROVIDED ON CURRENT PATIENT STATUS, OTHER SPECIFIC PATIENT INFORMATION, AND OUTCOME OF EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 16467625 ↗
• InjuryMar 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  CUSTOMER INITIALLY REPORTED THE GIBSON BONE GRAFT PLUG WAS CAUSING HEALING ISSUES WITH "A NUMBER OF PATIENTS." ADDITIONAL, LIMITED INFORMATION WAS PROVIDED. CUSTOMER STATED AT LEAST FIVE PATIENTS EXPERIENCED HEALING ISSUES. FOR PATIENT 2 OF 5, THE BONE GRAFT APPEARED TO QUICKLY SWELL, APPEAR INFECTED AND EXTRUDE FROM THE EXTRACTION SITE. A FEW DAYS AFTER IMPLANTATION (IMPLANT DATE NOT PROVIDED), PATIENT RETURNED TO THE OFFICE AND REPORTED HAVING A "TERRIBLE TASTE AND SMELL." MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE GRAFT AND CLEAN THE EXTRACTION SITE. AFTER THE INITIAL INTERVENTION, CUSTOMER REPORTED THAT SOME PATIENTS HAD TO RETURN TO THE OFFICE "A FEW TIMES" TO REMOVE THE GRAFT MATERIAL THAT CONTINUED TO EXTRUDE AND CLEAN AND IRRIGATE THE SITES. IT WAS NOT SPECIFIED HOW MANY PATIENTS HAD TO RETURN TO THE OFFICE, NOR WAS IT SPECIFIED HOW MANY TIMES THE PATIENTS HAD TO RETURN TO THE OFFICE. CUSTOMER STATED THIS CAUSED DELAYED HEALING AND PATIENT PAIN. CUSTOMER CONFIRMED "PATIENTS ARE FINE NOW." HOWEVER, THERE WAS NO INFORMATION PROVIDED ON CURRENT PATIENT STATUS, OTHER SPECIFIC PATIENT INFORMATION, AND OUTCOME OF EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 16467624 ↗