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 2019-01-22 for ENDOBON XENOGRAFT GRANULES 0.5ML N/A ROX05 manufactured by Biomet France S.a.r.l..
[133713237]
(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 device manufacturing quality record indicates that the released product met all requirements to perform as intended. According to the available data, the exact root cause cannot be determined. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[133713238]
It was reported that following a non integration of the biomaterial, the bone material was not compacted, which resulted in implant failure. The biomaterial was placed on (b)(6) 2017, implant was placed on (b)(6) 2018 and non integration appeared on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006946279-2019-00057 |
| MDR Report Key | 8266273 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-01-22 |
| Date of Report | 2019-01-21 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2018-11-09 |
| Device Manufacturer Date | 2017-05-22 |
| Date Added to Maude | 2019-01-22 |
| 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. 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 | 2019-01-22 |
| Model Number | N/A |
| Catalog Number | ROX05 |
| Lot Number | W0223146 |
| Device Expiration Date | 2018-10-31 |
| Operator | LAY USER/PATIENT |
| 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. Hospitalization; 2. Required No Informationntervention | 2019-01-22 |