MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-01-12 for ENDOBON? XENOGRAFT GRANULES 1.0ML N/A ROX10 manufactured by Biomet France S.a.r.l..
[97270746]
(b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. The device was used.
Patient Sequence No: 1, Text Type: N, H10
[97270747]
It was reported the bone graft was rejected immediately after placement. Durulent drainage at graft site, non integration xenograft working out of gingiva. Delayed healing, infection and inflammation. No implant was placed at the site due to the non-integration. No further information has been made available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006946279-2018-00013 |
| MDR Report Key | 7187589 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-01-12 |
| Date of Report | 2019-01-18 |
| Date Mfgr Received | 2019-01-17 |
| Device Manufacturer Date | 2017-06-02 |
| Date Added to Maude | 2018-01-12 |
| 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 | MS. H BATAILLE |
| Manufacturer Street | PLATEAU DE LAUTAGNE BP75 |
| Manufacturer City | VALENCE IN 26903 |
| Manufacturer Country | FR |
| Manufacturer Postal | 26903 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | BIOMET FRANCE S.A.R.L. |
| Manufacturer Street | PLATEAU DE LAUTAGNE BP75 |
| Manufacturer City | VALENCE CEDEX 26903 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 26903 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOBON? XENOGRAFT GRANULES 1.0ML |
| Generic Name | BONE GRAFTING MATERIAL, SYNTHETIC |
| Product Code | LYC |
| Date Received | 2018-01-12 |
| Model Number | N/A |
| Catalog Number | ROX10 |
| Lot Number | X0022159 |
| ID Number | (01) 03599870091265 |
| Device Expiration Date | 2018-11-30 |
| Operator | DENTIST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET FRANCE S.A.R.L. |
| Manufacturer Address | PLATEAU DE LAUTAGNE BP75 VALENCE CEDEX 26903 FR 26903 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-01-12 |