MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-09-12 for CARBIDE BUR CAVITY ROUND FG023 UNK E012337102300 manufactured by Maillefer Instruments Holding Sarl.
[120014538]
Per condition #1 of exemption (b)(4), events meeting the definition of a serious injury are required to be reported. Therefore, because of the separated piece was 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
[120014539]
In this event it was reported that a carbide bur cavity round separated during use; the customer had to perform surgery to remove the broken piece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8031010-2018-00113 |
| MDR Report Key | 7870533 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-09-12 |
| Date of Report | 2018-09-11 |
| Date Mfgr Received | 2018-08-17 |
| Date Added to Maude | 2018-09-12 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KARL NITTINGER |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494424 |
| Manufacturer G1 | MAILLEFER INSTRUMENTS HOLDING SARL |
| Manufacturer Street | CH. DU VERGER 3 |
| Manufacturer City | BALLAIGUES VAUD, CH-1338 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-1338 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARBIDE BUR CAVITY ROUND FG023 |
| Generic Name | TUNGSTEN CARBIDE, ROUND |
| Product Code | EJL |
| Date Received | 2018-09-12 |
| Model Number | UNK |
| Catalog Number | E012337102300 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAILLEFER INSTRUMENTS HOLDING SARL |
| Manufacturer Address | CH. DU VERGER 3 BALLAIGUES VAUD, CH-1338 SZ CH-1338 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-12 |