Skip to content

Geistlich Bio-Oss Pen® 20115Recalls & reported problems

Geistlich Pharma AG · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07610221010493), received between Oct 6, 2020 and Oct 6, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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

Device problems

  • Physical Resistance/Sticking1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 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 10639933 ↗

Other Bone Grafting Material, Animal Source devices

All Bone Grafting Material, Animal Source devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.