MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-28 for GEISTLICH BIO-OSS PEN 20116 manufactured by Geistlich Pharma Ag.
[147173389]
Device evaluation underway, to be completed.
Patient Sequence No: 1, Text Type: N, H10
[147173390]
Geistlich bio-oss pen is geistlich bio-oss granules (i. E. Bone mineral) in a syringe-like applicator. Geistlich bio-oss pen consists of 7 components. Among others, a filter cap which is used while wetting the bone grafting material with saline or blood and, subsequently, taken off to be replaced by a separate applicator tip. Geistlich pharma (b)(4) has received a complaint from a customer in the (b)(6) related to the green filter cap of the geistlich bio-oss pen?. The customer reports that, after unscrewing the green filter cap from geistlich bio-oss pen? , a visible particle of green color was seen on the outer barrel of the pen. Geistlich has not received any reports of patient injury or harm related to this issue. The filter caps of the geistlich bio-oss pen? Are sterilised, tested as packaging material and approved according to international standards, including testing as medical grade packaging material. In the highly unlikely case that a particle of the filter cap material enters the geistlich bio-oss? Bone graft substitute during implantation, tissue reactions cannot be completely ruled out. The customer reports observing this issue up to seven times and recently reported to the company. In the 7 reported cases from one single user from the (b)(6), the loose particle was always found on the outside of the applicator. In each case, the particle was discovered by the physician before use of the product. Earlier reports were escalated and assessed in a dedicated issue review. The investigations showed that the supplier of the filter cap could exclude any errors during the manufacturing of the filter cap and two batches of in-stock filter caps did not show any presence of loose particles. Since no other complaint was present and the described error could not be reproduced, these cases were not reported at that time. Eventually, the receipt of the present case led to the next escalation step, a health hazard evaluation, and the necessity of an mdr-filing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614442-2019-00001 |
| MDR Report Key | 8460431 |
| Date Received | 2019-03-28 |
| Date of Report | 2019-06-13 |
| Date of Event | 2019-02-28 |
| Date Mfgr Received | 2019-02-28 |
| Device Manufacturer Date | 2018-01-31 |
| Date Added to Maude | 2019-03-28 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. SEBASTIAN CAVALLI |
| Manufacturer Street | BAHNHOFSTRASSE 40 |
| Manufacturer City | WOLHUSEN, 6110 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 6110 |
| Manufacturer G1 | GEISTLICH PHARMA AG |
| Manufacturer Street | BAHNHOFSTRASSE 40 |
| Manufacturer City | WOLHUSEN, 6110 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | ERS190007 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GEISTLICH BIO-OSS PEN |
| Generic Name | BONE GRAFTING MATERIAL |
| Product Code | NPM |
| Date Received | 2019-03-28 |
| Returned To Mfg | 2019-03-13 |
| Model Number | 20116 |
| Lot Number | 81801126 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GEISTLICH PHARMA AG |
| Manufacturer Address | BAHNHOFSTRASSE 40 WOLHUSEN, 6110 SZ 6110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-28 |