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Geistlich Bio-Oss® 20113Recalls & reported problems

Geistlich Pharma AG · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07610221010325), received between Oct 6, 2022 and Oct 6, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Biocompatibility” (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

  • Adverse Event Without Identified Device or Use Problem1
  • Biocompatibility1
  • Insufficient Device Problem Information1

Patient problems

  • Hypersensitivity/Allergic reaction1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 6, 2022Biocompatibility; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Biocompatibility; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

    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.

    Patient problems: Hypersensitivity/Allergic reaction

    MAUDE report 15550848 ↗

Other Bone Grafting Material, Animal Source devices

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