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.
[21540280]
The doctor states he placed bone grafting material roap05 at tooth sight #20. Infection was seen 1 week post op and antibiotics were prescribed.
Patient Sequence No: 1, Text Type: D, B5
[21704828]
Product remains implanted and will not be returned to manufacturer for evaluation. Single use.
Patient Sequence No: 1, Text Type: N, H10
[23605186]
Method: - no testing methods performed unable to be selected. Results:? No results available since no evaluation performed unable to be selected. The product was not returned for evaluation, as it was used, therefore the complaint cannot be verified. The device history record review was completed by interpore cross. Product passed all quality control measures and no non-conformances were observed. The complaint lot history review was completed and no other complaints were reported. No deviations were identified through the investigation performed, that may have contributed to the reported event. A definitive root cause has not been determined.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 0001038806-2015-00694 |
MDR Report Key | 4815049 |
Report Source | 05,HEALTH PROFESSIONAL |
Date Received | 2015-06-03 |
Date of Report | 2015-05-12 |
Date of Event | 2015-04-16 |
Date Mfgr Received | 2015-07-30 |
Device Manufacturer Date | 2014-07-22 |
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 | 773420 |
Device Expiration Date | 2016-07-22 |
Operator | OTHER HEALTH CARE PROFESSIONAL |
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. Other | 2015-06-03 |