Geistlich Bio-Oss Pen® 20116Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07610221010509), received between Mar 28, 2019 and Oct 6, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Disintegration” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2020Physical Resistance/Sticking

  A USER REPORTED THAT THEY EXPERIENCED DIFFICULTY IN DISPENSING BIO-OSS GRANULES FROM THE GEISTLICH BIO-OSS PEN (GBOP). SPECIFICALLY IT WAS REPORTED THAT THERE APPEARED TO BE RESISTANCE TO THE PLUNGER PROGRESSION IN THE SYRINGE-LIKE CONFIGURATION OF THE PEN. IT WAS REPORTED THAT IT SEEMS TO GET CAUGHT SOMEWHERE IN THE BARREL AND THEN WILL SUDDENLY RELEASE AND THE BIO-OSS GRANULES SPILL OUT. AS RESULT THE USER COMPLETED THE TREATMENT HAVING EMPTIED THE PEN INTO A DISH AND THEN SCOOPED THE GRANULES AND PLACED INTO THE TREATMENT SITE. GEISTLICH BIO-OSS PEN IS A PRODUCT VARIANT PROVIDING EASE OF USE IN A SYRINGE-LIKE DISPENSER CONFIGURATION. THE PEN CONTAINS NATURAL BONE MINERAL FOR FILLING OF BONE DEFECTS IN MAXILLOFACIAL SURGERY, IMPLANTOLOGY, AND PERIODONTOLOGY. THE MATERIAL CONSISTS OF ANORGANIC BOVINE BONE MINERAL WHICH IS PROVIDED IN A SYRINGE-LIKE APPLICATOR. GEISTLICH BIO-OSS PEN CONSISTS OF 7 COMPONENTS WHICH ARE FULLY ASSEMBLED AND STERILIZED THEN DISTRIBUTED BY THE MANUFACTURER. ONE OF THE COMPONENTS IS A SILICONE PLUNGER WHICH OPERATES WITHIN THE BARREL OF THE SYRINGE. GEISTLICH PHARMA IS INVESTIGATING THIS COMPLAINT FULLY TO DETERMINE POTENTIAL CAUSE OF THE PRODUCT PROBLEM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10639931 ↗
• MalfunctionMar 28, 2019Material Disintegration

  ON 03/29/2019 A CORRECTION OR REMOVAL REPORT WAS FILED. THE CORRECTION OR REMOVAL CONSISTS OF A CORRECTIVE NOTICE WHICH, AMONG OTHER ACTIONS, ASKED THE DISTRIBUTOR TO INFORM ALL CUSTOMERS THEY HAVE SUPPLIED WITH GEISTLICH BIO-OSS PEN® IN THE LAST THREE YEARS (I.E. SHELF-LIFE OF GEISTLICH BIO-OSS PEN) ABOUT THE ISSUE AND ASKED USERS TO REPORT ANY DETECTED PARTICLES TO THE DISTRIBUTOR, WHO WILL INFORM GEISTLICH PHARMA AG. UP TO DATE (AFTER SENDING OUT A CORRECTIVE NOTICE), WORLDWIDE CUSTOMERS REPORT OBSERVING THIS ISSUE UP TO FOURTEEN TIMES (SEVENTEEN AFFECTED PRODUCT UNITS) AND REPORTED TO THE COMPANY. FOUR OF THESE CASES (FOUR AFFECTED PRODUCT UNITS) OCCURRED IN THE US AND INCLUDE HISTORICAL/ANECDOTAL CASES. THE LOOSE PARTICLE WAS ALWAYS FOUND ON THE OUTSIDE OF THE APPLICATOR. IN EACH CASE THE PARTICLE WAS DISCOVERED BY THE PHYSICIAN BEFORE USE OF THE PRODUCT. A THOROUGH INSPECTION OF THE COLOR AND THE SHAPE OF EITHER THE LOOSE PARTICLE AND THE DEFECT AT THE FILTER CAP (TOOTHED LOCK MECHANISM AT THE BOTTOM) PROVED THE PARTICLE TO BE FORMERLY PART OF THE FILTER CAP COMPONENT WHICH TEARED OFF WHILE OVERSTRESSING THE TOOTHED LOCK MECHANISM WITH SHEAR FORCES IN THE UNSCREW PROCESS. THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8460431 ↗