MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-07-29 for PEPGEN P-15 99U000102 manufactured by Dentsply Tulsa Dental Specialties.
[6190682]
In this event it was reported that pepgen p-15 bone grafting material pulled away from the extraction socket wall in a patient. The dentist removed the material and completed the procedure using another bone grafting material.
Patient Sequence No: 1, Text Type: D, B5
[14216785]
Therefore, because intervention was required, this event is reportable per 21 part 803. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2320721-2015-00009 |
| MDR Report Key | 4961223 |
| Report Source | 05 |
| Date Received | 2015-07-29 |
| Date of Report | 2014-11-26 |
| Date Mfgr Received | 2014-11-26 |
| Date Added to Maude | 2015-08-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | SUSQUEHANNA COMMERCE CTR W. 221 W. PHILADELPHIA ST., STE. 60 |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PEPGEN P-15 |
| Generic Name | BONE GRAFTING MATERIAL |
| Product Code | NPZ |
| Date Received | 2015-07-29 |
| Catalog Number | 99U000102 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY TULSA DENTAL SPECIALTIES |
| Manufacturer Address | JOHNSON CITY TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-07-29 |