MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-16 for BIO - OSS manufactured by Geistlich Pharma.
[31702642]
Dr. (b)(6) of (b)(6) used bio oss, lot #100412, to fill the area of extracted tooth #14 on (b)(6) 2011. After i made numerous requests to pull tooth #15 as it was infected, painful and very loose dr. (b)(6) extracted it on (b)(6)2012. Dr. (b)(6) told me i had squamous cell carcinoma in the #15, #14, #13 area on (b)(6) 2014. The cancer, stage #4 squamous cell carcinoma, was confirmed by biopsy on (b)(6) 2014. Complete maxillary bone removal from #15 thru #11 was performed on (b)(6) 2014. Dates of use: (b)(6) 2011.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057958 |
| MDR Report Key | 5236569 |
| Date Received | 2015-11-16 |
| Date of Report | 2015-11-16 |
| Date of Event | 2014-02-04 |
| Date Added to Maude | 2015-11-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BIO - OSS |
| Generic Name | DENTAL BONE VOID FILLER |
| Product Code | NPM |
| Date Received | 2015-11-16 |
| Lot Number | 100412 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GEISTLICH PHARMA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Deathisabilit | 2015-11-16 |