MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-05-27 for CANCELLOUS, MINERALIZED, 0.5CC, 300-500?M RMCA305 manufactured by Biomet 3i.
[5833688]
The dentist reported that the patient presented with severe post operative pain causing this bone graft to have to be removed.
Patient Sequence No: 1, Text Type: D, B5
[13413466]
This product was discarded by the dentist.
Patient Sequence No: 1, Text Type: N, H10
[23604337]
The investigation review was completed by the manufacturer (b)(4). The device history record review was completed and no non conformance/capa activities were found for this lot that would cause or contribute to the reported event. The product passed all quality control measures and no nonconformances were observed. The lot history review was completed. The donor charts were reviewed and there are no issues with the serology reports or microbiology cultures. The donor was processed in compliance with all regulatory standards and following all (b)(4) established procedures. No deviations were identified through the investigation performed that may have contributed to the reported event. No cause was identified through complaint investigation process. Definitive root cause could not be determined for this complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001038806-2015-00678 |
| MDR Report Key | 4799905 |
| Report Source | 05 |
| Date Received | 2015-05-27 |
| Date of Report | 2015-04-30 |
| Date of Event | 2015-03-17 |
| Date Mfgr Received | 2015-07-10 |
| Device Manufacturer Date | 2014-09-04 |
| Date Added to Maude | 2015-05-28 |
| 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 | 0 |
| Event Location | 0 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CANCELLOUS, MINERALIZED, 0.5CC, 300-500?M |
| Generic Name | CANCELLOUS MINERALIZED BONE |
| Product Code | NUN |
| Date Received | 2015-05-27 |
| Catalog Number | RMCA305 |
| Lot Number | 0127160173 |
| Device Expiration Date | 2019-09-04 |
| 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 | 2015-05-27 |