MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2015-06-03 for DEMINERALIZED BONE MATRIX (DMB) 0.5CC ROAP05 manufactured by Biomet 3i.
[5923577]
The doctor states that he place the bone graft material roap05 in tooth site #17/18 at time of extraction. Infection was seen 10 days post op, doctor prescribed antibiotics. Despite the two rounds of antibiotics the doctor states that he debrided the bone grafted area of tooth site #17.
Patient Sequence No: 1, Text Type: D, B5
[13342936]
The product was removed and was discarded, it will not be returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001038806-2015-00702 |
| MDR Report Key | 4815120 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2015-06-03 |
| Date of Report | 2015-05-12 |
| Date of Event | 2015-03-09 |
| Date Mfgr Received | 2015-07-29 |
| Device Manufacturer Date | 2014-05-08 |
| Date Added to Maude | 2015-06-03 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DANIA PEREZ |
| Manufacturer Street | 4555 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal | 33410 |
| Manufacturer Phone | 5617766700 |
| Manufacturer G1 | BIOMET 3I |
| Manufacturer Street | 4555 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33410 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEMINERALIZED BONE MATRIX (DMB) 0.5CC |
| Generic Name | ALLOGRAFT PUTTY |
| Product Code | NUN |
| Date Received | 2015-06-03 |
| Catalog Number | ROAP05 |
| Lot Number | 993020 |
| Device Expiration Date | 2016-05-08 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET 3I |
| Manufacturer Address | 4555 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-03 |