MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-07-17 for DBM AND MINERALIZED ALLOGRAFT IN A LECITHIN CARRIER ROAPM20 manufactured by Interpore Cross International.
[80126811]
Device was discarded by the customer.
Patient Sequence No: 1, Text Type: N, H10
[80126812]
The doctor reported that a patient had immediate socket grafting (roapm20) done in tooth location #19 on (b)(6) 2017. The patient returned on (b)(6) 2017 with severe pain, similar to dry socket pain. Loss of graft/non-integration was evident despite covering the site with crisscross sutures & resorbable collagen dressing. The extraction of the allograft was straight forward.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001038806-2017-00425 |
| MDR Report Key | 6716672 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-07-17 |
| Date of Report | 2017-10-20 |
| Date of Event | 2017-06-11 |
| Date Mfgr Received | 2017-10-02 |
| Date Added to Maude | 2017-07-17 |
| 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 | DENTIST |
| 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 | INTERPORE CROSS INTERNATIONAL |
| Manufacturer Street | 181 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 926182402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 926182402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DBM AND MINERALIZED ALLOGRAFT IN A LECITHIN CARRIER |
| Generic Name | ALLOGRAFT PUTTY |
| Product Code | NUN |
| Date Received | 2017-07-17 |
| Catalog Number | ROAPM20 |
| Lot Number | 009050 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERPORE CROSS INTERNATIONAL |
| Manufacturer Address | 181 TECHNOLOGY DRIVE IRVINE CA 926182402 US 926182402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-17 |