MAUDE Adverse Event Report: GEISTLICH BIO-OSS PEN; BONE GRAFTING MATERIAL

Model Number	20115
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation underway, to be completed.
Event or Problem Description
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 as reported.

• Brand Name: GEISTLICH BIO-OSS PEN
• Common Device Name: BONE GRAFTING MATERIAL
• MDR Report Key: 10639933
• Report Number: 9614442-2020-00003
• Device Sequence Number: 2961755
• Product Code: NPM
• UDI-Device Identifier: 07610221010493
• UDI-Public: (01)07610221010493(17)230117(10)82000456
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/17/2023
• Device Model Number: 20115
• Device Lot Number: 82000456
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 10/06/2020
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1