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 2019-02-01 for ENDOBON XENOGRAFT GRANULATES LARGE 8 ML N/A ROXLG80 manufactured by Biomet France S.a.r.l..
[134752227]
(b)(4). Report source, foreign - event occurred in (b)(6). The device will not be returned to the manufacturer. Therefore it will not be analyzed. The device history record has been reviewed. No discrepancies were found. With the available information, the exact 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. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[134752228]
The doctor reported an allergic reaction to endobon product. The doctor reported that sinus lift in tooth position 16 was performed on (b)(6) 2018. 7 days later, after medication treatment had already been finished, the patient developed an allergic reaction with exanthem and itch. The symptoms appeared in particular in the face, on the neck and cleavage, not in the patient mouth. Cortisone treatment was performed. As patient's condition did not improve, doctor removed completely the endobon product on (b)(6) 2018. Information on patient health status received the (b)(6) 2018 confirmed that the patient is well and the allergy has gone. 2 endobon products were involved in this event. The investigation for the second endobon product is performed in the report for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006946279-2019-00085 |
| MDR Report Key | 8297519 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-02-01 |
| Date of Report | 2019-02-01 |
| Date of Event | 2018-05-24 |
| Date Mfgr Received | 2018-05-25 |
| Device Manufacturer Date | 2018-01-03 |
| Date Added to Maude | 2019-02-01 |
| 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 GRANULATES LARGE 8 ML |
| Generic Name | BONE GRAFTING MATERIAL, SYNTHETIC |
| Product Code | LYC |
| Date Received | 2019-02-01 |
| Model Number | N/A |
| Catalog Number | ROXLG80 |
| Lot Number | X0273004 |
| Device Expiration Date | 2019-06-30 |
| 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 | 2019-02-01 |