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 1.0 ML ROX10 manufactured by Biomet France S.a.r.l..
[107350262]
(b)(4). Report source, foreign - event occurred in (b)(6). Conclusion: the device could not be evaluated as it remained implanted. The device history record (dhr) was reviewed and no discrepancies were found. No similar complaint has been registered on the batch involved in this event. According to the available information, the root cause regarding this event could not be determined. If any further information is found which could change or alter any conclusions or information, a supplemental report will be filed accordingly.
Patient Sequence No: 1, Text Type: N, H10
[107350263]
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 | 3006946279-2018-00150 |
| MDR Report Key | 7486937 |
| 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 | 2017-03-27 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOBON XENOGRAFT GRANULES 1.0 ML |
| Generic Name | BONE GRAFTING MATERIAL, SYNTHETIC |
| Product Code | LYC |
| Date Received | 2018-05-04 |
| Catalog Number | ROX10 |
| Lot Number | W0162089 |
| ID Number | (01) 03599870091265 |
| Device Expiration Date | 2018-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 |