MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2018-02-28 for ZEKRYA BUR E015114100000 manufactured by Dentsply Maillefer.
[101236644]
Per condition #1 of exemption (b)(4), events meeting the definition of a serious injury are required to be reported. Therefore, because of the possibility that the separated piece will need to be removed surgically, this event meets the criteria for reportability 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
[101236645]
In this event it was reported that a zekrya bur separated during use; as of this mdr evaluation, the separated piece remains in the patient's jaw (soft tissue).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8031010-2018-00028 |
| MDR Report Key | 7304280 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2018-02-28 |
| Date of Report | 2018-02-28 |
| Date Mfgr Received | 2018-01-29 |
| Date Added to Maude | 2018-02-28 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494229 |
| Manufacturer G1 | DENTSPLY MAILLEFER |
| Manufacturer Street | CHEMIN DU VERGER 3 |
| Manufacturer City | BALLAIGUES, 1338 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 1338 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZEKRYA BUR |
| Generic Name | BUR, DENTAL |
| Product Code | EJL |
| Date Received | 2018-02-28 |
| Model Number | NA |
| Catalog Number | E015114100000 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY MAILLEFER |
| Manufacturer Address | CHEMIN DU VERGER 3 BALLAIGUES, 1338 SZ 1338 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-02-28 |