MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2017-02-21 for ENDOBON XENOGRAFT GRANULES N/A manufactured by Biomet France S.a.r.l..
[67846445]
The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event. Lee et al. "a retrospective study of complications associated with 100 consecutive maxillary sinus augmentations via the lateral window approach" the international journal of oral & maxillofacial implants (2013) 28:860-868.
Patient Sequence No: 1, Text Type: N, H10
[67846446]
It was reported in a journal article, one patient experienced excessive bone resorption 6 months post-operatively. Possible small sinus membrane perforations during bone graft packing, sneezing, or blowing the nose at the initial stage of healing, or incomplete elevation of the sinus membrane from the medial wall of the sinus may have caused the bone loss.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006946279-2017-00046 |
| MDR Report Key | 6345689 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2017-02-21 |
| Date of Report | 2017-01-23 |
| Date Mfgr Received | 2017-01-23 |
| Date Added to Maude | 2017-02-21 |
| 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 | 2017-02-21 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | PHYSICIAN |
| 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. Other | 2017-02-21 |