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 2018-05-04 for ENDOBON XENOGRAFT GRANULES 2.0 ML ROX20 manufactured by Biomet France S.a.r.l..
[107350401]
(b)(4). Report source, foreign - event occurred in (b)(6). The investigation is in process. Once it has been completed, a follow-up mdr will be submitted. Product not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[107350402]
It has been reported that a patient experienced side effects comparable to the side effects described in the field safety notice of the endobon fsca zfa 2015-03 (initiated in january 2016). The patient has been implanted in (b)(6) 2017, and the surgeon wondered if the implanted endobon was within the scope of the zfa 2015-03. First investigation showed that the product implanted to the patient was not within the scope of the recall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006946279-2018-00151 |
| MDR Report Key | 7486940 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-05-04 |
| Date of Report | 2019-01-28 |
| Date Mfgr Received | 2019-01-17 |
| Device Manufacturer Date | 2016-09-19 |
| Date Added to Maude | 2018-05-04 |
| 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 | PHARMACIST |
| 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 2.0 ML |
| Generic Name | BONE GRAFTING MATERIAL, SYNTHETIC |
| Product Code | LYC |
| Date Received | 2018-05-04 |
| Catalog Number | ROX20 |
| Lot Number | W0075265 |
| ID Number | (01) 03599870091272 |
| Device Expiration Date | 2018-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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. Other | 2018-05-04 |