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 2019-12-16 for ENDOBON? XENOGRAFT GRANULES 0.5ML ROX05 manufactured by Biomet France S.a.r.l..
[171977684]
(b)(4). Report source, foreign: event occurred in (b)(6). The device was not returned to the manufacturer. Therefore it could not be analyzed. The review of the device manufacturing quality record indicates that 694 products endobon xenograft granules 0. 5ml, reference (b)(4) batch u0153300 were manufactured on 12 november 2014. The device manufacturing quality record indicates that the released product met all requirements to perform as intended. No non conformity or deviation was observed which could be linked to the event described in the complaint. The investigation is in progress. Once the investigation has been completed, a follow-up mdr will be submitted. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.
Patient Sequence No: 1, Text Type: N, H10
[171977685]
It was reported by the doctor the non integration of endobon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006946279-2019-00547 |
| MDR Report Key | 9472149 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-12-16 |
| Date of Report | 2020-03-11 |
| Date of Event | 2018-10-13 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2014-11-12 |
| Date Added to Maude | 2019-12-16 |
| 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 |
| 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 |
| 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 | 2019-12-16 |
| Model Number | ROX05 |
| Catalog Number | ROX05 |
| Lot Number | U0153300 |
| Device Expiration Date | 2017-09-30 |
| 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. Required No Informationntervention | 2019-12-16 |