MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,health profe report with the FDA on 2017-04-13 for ENDOBON N/A ROXLG50 manufactured by Biomet France S.a.r.l..
[72778196]
(b)(4). 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
[72778197]
It was reported a patient underwent removal of bone graft and dental implant due to infection and non-integration seven days post-implantation.
Patient Sequence No: 1, Text Type: D, B5
[79313127]
This follow up report is being filed to relay corrected and additional information. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006946279-2017-00066 |
| MDR Report Key | 6491648 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2017-04-13 |
| Date of Report | 2017-06-23 |
| Date of Event | 2016-01-28 |
| Date Mfgr Received | 2017-05-29 |
| Device Manufacturer Date | 2014-10-10 |
| Date Added to Maude | 2017-04-13 |
| 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. 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 |
| Generic Name | BONE GRAFTING MATERIAL, SYNTHETIC |
| Product Code | LYC |
| Date Received | 2017-04-13 |
| Model Number | N/A |
| Catalog Number | ROXLG50 |
| Lot Number | U0172286 |
| ID Number | SEE H10 NARRATIVE |
| Device Expiration Date | 2017-09-30 |
| Operator | PHYSICIAN |
| 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 | 2017-04-13 |