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 2017-04-07 for ENDOBON XENOGRAFT GRANULES N/A ROXLG80 manufactured by Biomet France S.a.r.l..
[72109385]
(b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Report source, foreign - event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[72109386]
It was reported patient underwent procedure for graft placement due to initial dental graft failure. The initial graft was found too soft and did not turn into bone after eight months. Attempts have been made and additional information on the reported event is unavailable at this time.
Patient Sequence No: 1, Text Type: D, B5
[79315732]
This follow up report is being filed to relay corrected and additional information. (b)(4). Reported event could not be confirmed. Dhr review found no discrepancies relevant to the reported event. Review of complaint history determined no further action is required. 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
| Report Number | 3006946279-2017-00062 |
| MDR Report Key | 6472041 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-04-07 |
| Date of Report | 2017-06-20 |
| Date of Event | 2016-07-12 |
| Date Mfgr Received | 2017-05-24 |
| Device Manufacturer Date | 2015-08-13 |
| Date Added to Maude | 2017-04-07 |
| 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. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| 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 |
| Generic Name | BONE GRAFTING MATERIAL, SYNTHETIC |
| Product Code | LYC |
| Date Received | 2017-04-07 |
| Model Number | N/A |
| Catalog Number | ROXLG80 |
| Lot Number | V0143230 |
| ID Number | SEE H10 NARRATIVE |
| Device Expiration Date | 2018-07-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-04-07 |