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.
[19808760]
The doctor states that he placed the bone graft material roap05 in tooth site #17 at time of extraction. Infection was seen 2 weeks post op. The doctor prescribed antibiotics.
Patient Sequence No: 1, Text Type: D, B5
[19876456]
The product remains implanted and will not be returned to the manufacturer. Single use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001038806-2015-00692 |
| MDR Report Key | 4815018 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2015-06-03 |
| Date of Report | 2015-05-12 |
| Date of Event | 2015-04-03 |
| Date Mfgr Received | 2015-08-19 |
| 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 | 081080 |
| 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 |