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.
[5923573]
The doctor states that he placed allograft material roap05 at the time of extraction in tooth site #17. Antibiotics were prescribed. Debridement was performed 17 days post-op, despite additional antibiotic treatment.
Patient Sequence No: 1, Text Type: D, B5
[13386759]
The product was removed and discarded, it will not be returned to the manufacturer for evaluation. Single use.
Patient Sequence No: 1, Text Type: N, H10
[24092036]
The product was not returned for evaluation, as it was used, therefore the complaint cannot be verified. Interpore cross could not identify the reported lot number. The customer order history was reviewed and the reported lot number could not be found, therefore the device history record review could not be performed. A definitive root cause has not been determined. Correction: deleted - initial reported lot number was incorrect and is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001038806-2015-00693 |
| MDR Report Key | 4815047 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2015-06-03 |
| Date of Report | 2015-05-12 |
| Date of Event | 2015-04-24 |
| 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 | 081010 |
| 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 |