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 2018-04-26 for ENDOBON? XENOGRAFT GRANULES 1.0ML ROX10 manufactured by Biomet France S.a.r.l..
[106604651]
(b)(4). Report source, foreign - event occurred in (b)(6). The product has not been returned to the manufacturer. Therefore, the product evaluation could not be performed. The dhr has been reviewed and no discrepancies were found. The root cause of the event could not be determined. 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
[106604652]
A non integration of the bone materials copios cancellous particulate xenograft 0. 25-1mm, 1,0 cc and endobon xenograft granules 1. 0 ml has been reported by the doctor petrement. The granules did not transform into bone. The patient had infection, inflammation, healing delay and pain. In anticipation of the placement of 3 implants 6 months later, the doctor performed a lateral sinus lift on (b)(6) 2017: the doctor used one copios cancellous particulate xenograft 0. 25-1mm, 1,0 cc, and used in addition to the filling two endobon xenograft granules 1. 0 ml. On (b)(6) 2018, the doctor saw the patient in consultation to proceed with the placement of 3 implants in the dental location 24, 25 and 26 (universal system of dental location). The doctor diagnosed that the site was not healthy. He found that the particulates were not processed, and a suspicious and "elastic" form was present. The doctor nevertheless placed the implants. The doctor proceeded to the removal of the material and the trimming on (b)(6) 2018 as the implants were not osseointegrated, the bone height was insufficient because the filling was not transformed. Additionally the patient had a slight pain, dr. Petrement found a beginning of inflammation of the gingiva and a presence of pus in the sinus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006946279-2018-00147 |
| MDR Report Key | 7464295 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-04-26 |
| Date of Report | 2018-04-26 |
| Date of Event | 2018-03-02 |
| Date Mfgr Received | 2018-03-30 |
| Device Manufacturer Date | 2017-04-07 |
| Date Added to Maude | 2018-04-26 |
| 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 CEDEX 26903 |
| Manufacturer Country | FR |
| Manufacturer Postal | 26903 |
| Manufacturer Phone | 0334757594 |
| 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 1.0ML |
| Generic Name | BONE GRAFTING MATERIAL, SYNTHETIC |
| Product Code | LYC |
| Date Received | 2018-04-26 |
| Catalog Number | ROX10 |
| Lot Number | W0173100 |
| ID Number | (01) 0 3599870 09126 5 |
| Device Expiration Date | 2018-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-04-26 |