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 2019-01-09 for ENDOBON XENOGRAFT GRANULES 0.5ML N/A ROX05 manufactured by Biomet France S.a.r.l..
[132527140]
(b)(4). Report source, foreign - event occurred in (b)(6). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[132527141]
It was reported that the product bone graft (endobon) did not seem to be integrated in six months even with the membrane used. The implant was placed on (b)(6) 2018 and was removed on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006946279-2018-00433 |
| MDR Report Key | 8231538 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-01-09 |
| Date of Report | 2019-06-21 |
| Date of Event | 2018-10-30 |
| Date Mfgr Received | 2019-05-28 |
| Device Manufacturer Date | 2016-01-13 |
| Date Added to Maude | 2019-01-09 |
| 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. CHRISTINA ARNT |
| Manufacturer Street | 56 E BELL DR |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| 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 0.5ML |
| Generic Name | BONE GRAFTING MATERIAL, SYNTHETIC |
| Product Code | LYC |
| Date Received | 2019-01-09 |
| Model Number | N/A |
| Catalog Number | ROX05 |
| Lot Number | V0171018 |
| Device Expiration Date | 2017-06-30 |
| Operator | LAY USER/PATIENT |
| 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 | 2019-01-09 |