MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-01-16 for ENDOBON XENOGRAFT GRANULES 0.5ML N/A ROX05 manufactured by Biomet France S.a.r.l..
[133181770]
(b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[133181771]
It was reported that biomaterial was not integrated, so bone material was not compacted after placing the implant, resulting in implant failure. Biomaterial placed on (b)(6) 2017, implant placed on (b)(6) 2017 and non integration appeared on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006946279-2019-00042 |
| MDR Report Key | 8251940 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-01-16 |
| Date of Report | 2019-01-23 |
| Date of Event | 2018-07-01 |
| Date Mfgr Received | 2019-01-22 |
| Device Manufacturer Date | 2015-07-23 |
| Date Added to Maude | 2019-01-16 |
| 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 | MS. H BATAILLE |
| Manufacturer Street | PLATEAU DE LAUTAGNE BP75 |
| Manufacturer City | VALENCE 26903 |
| Manufacturer Country | FR |
| Manufacturer Postal | 26903 |
| Manufacturer Phone | 0334757591 |
| 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 0.5ML |
| Generic Name | BONE GRAFTING MATERIAL, SYNTHETIC |
| Product Code | LYC |
| Date Received | 2019-01-16 |
| Model Number | N/A |
| Catalog Number | ROX05 |
| Lot Number | V044208B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-01-16 |