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

Model Number	20113
Medical Device Problem Codes	Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	08/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Possible side effects which may occur are listed in respective product ifu: adverse reactions: (bio-oss).Incompatibility reactions with geistlich bio-oss® cannot be excluded.Possible complications which may occur with any surgery include swelling at the surgical site, flap sloughing, bleeding, local inflammation, bone loss, infection or pain.Geistlich® bio-oss is a bovine bone-derived material obtained separating the mineral part of the bone from all organic material.Consequently, it is theoretically free of potential allergens, as expected from the fact that the levels of organic substances in geistlich® bio-oss are under the detection limit of the current methodology.Additional information had been inquired but despite the efforts made additional data requested were not provided in order to perform the evaluation.Based on the information received, it is not clear why in this case the clinical outcome has not been successful as expected.There are no details with respect to the choice of treatment method intra-operative and post-surgical medications which could negatively influence the outcome of the treatment.
Event or Problem Description
Patient contacted manufacturer directly and reported to have suffered a possible allergic reaction to a tooth extraction and bone grafting procedure where the clinician used bio-oss and bio-gide.The dental practice confirmed that the patient is progressing clinically as expected.Otherwise no medical records are available to the manufacturer.Manufacturer has evaluated manufacturing records for the products used in the procedure and no deviations from manufacturing requirements or quality requirements are observed.Manufacturer confirmed that these lot numbers correlate with orders shipped to dental practice; bio-oss 82100624; expiration date 13 dec 2024 and bio-gide 82001253 expiration date 03 aug 2022.This report reflects the same event as report 9614442-2022-00003, reported separately as two different geistlich products used in procedure.

• Brand Name: GEISTLICH BIO-OSS
• Common Device Name: BONE GRAFTING MATERIAL
• Manufacturer (Section D): GEISTLICH PHARMA AG; bahnhofstrasse 40; wolhusen, 6110 ; SZ 6110
• Manufacturer (Section G): GEISTLICH PHARMA AG; bahnhofstrasse 40; wolhusen, 6110 ; SZ 6110
• Manufacturer Contact: sandra krummenacher ; bahnhofstrasse 40; wolhusen, 6110 ; SZ 6110
• MDR Report Key: 15550848
• Report Number: 9614442-2022-00002
• Device Sequence Number: 14971809
• Product Code: NPM
• UDI-Device Identifier: 07610221010325
• UDI-Public: (01)07610221010325(17)241213(10)82100624
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/13/2024
• Device Model Number: 20113
• Device Lot Number: 82100624
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown