MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-14 for GUIDOR C11 manufactured by Degradable Solutions Ag.
[133047226]
The first original report was sent to fda over fedex on (b)(6) 2018 s. This is an electronic version. The dentist was repeatedly asked what periodontal treatment was made prior to the implantation and what the periodontal status was, lot-number, whether one or both tooth extraction sites were affected etc. No reply till (b)(6). Root cause: the device did not likely cause or contribute to the adverse event (the device did not fail, is not improperly or inadequately designed or manufactured and was not subject to user error due to inadequate labeling). Due to the lack of information about the lot an article number the documentation from all possible lots was reviewed. No deviation was discovered. It is possible that the periodontal infection was not completely eliminated prior to the application of the grafting material. It is also possible then using biomaterials that do not resorb quickly (such as bgs or membrane) that a small infection can linger for over several months until it breaks out and becomes apparent. Also it can not be excluded that the infection came from outside during the healing.
Patient Sequence No: 1, Text Type: N, H10
[133047227]
The dentist in (b)(6) extracted two teeth from sites 33 and 43 in (b)(6) 2017 due to a moderate periodontal bone loss (indicates preceding periodontal bone loss infection) and applied easy-graft classic for bone grafting. No implants were placed. According to the dentist, the sites were not infected/inflamed prior to the application of easy-graft classic (product group c11, lot-number currently unknown). The healing process was uneventfully for 6 months, but the patient reconsulted the dentist 8 months after bone grafting with a severe infection (it is currently unknown whether one or both tooth-extractions sites were affected). The first symptoms were reported by the patient in (b)(6) 2018. The dentist found an abscess in the area of the grafted socket (s). The patient was hospitalized in (b)(6) 2018. Therefore, the easy-graft classic material was removed from the site (s) and drains were applied by an oral surgeon. According to the provided information, the patient i currently symptom-free.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004108559-2019-00001 |
| MDR Report Key | 8243950 |
| Date Received | 2019-01-14 |
| Date of Report | 2019-01-14 |
| Date of Event | 2018-06-01 |
| Date Mfgr Received | 2018-11-26 |
| Date Added to Maude | 2019-01-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ALEXANDER LORENZ |
| Manufacturer Street | WAGISTRASSE 23 |
| Manufacturer City | SCHLIEREN, ZURICH 8952 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 8952 |
| Manufacturer G1 | DEGRADABLE SOLUTIONS AG |
| Manufacturer Street | WAGISTRASSE 23 |
| Manufacturer City | SCHLIEREN, ZURICH 8952 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8952 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GUIDOR |
| Generic Name | EASY-GRAFT CLASSIC |
| Product Code | LYC |
| Date Received | 2019-01-14 |
| Model Number | C11 |
| Catalog Number | C11 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEGRADABLE SOLUTIONS AG |
| Manufacturer Address | WAGISTRASSE 23 SCHLIEREN, ZURICH 8952 SZ 8952 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-01-14 |