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.
[6190685]
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
[13515369]
Therefore, because intervention was required, this event is reportable per 21 cfr 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 | 2320721-2015-00008 |
MDR Report Key | 4961207 |
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 |