MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-28 for BURR ROUND M DIAMETER 2.5MM 03.000.007S manufactured by Depuy Synthes Products Llc.
[146341602]
Udi? (b)(4). Device manufacture date: the device manufacture date is unavailable. The manufacturing location was unknown. As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[146341603]
It was reported from (b)(6) that during a maxillofacial surgical trial, the desired dental section could not be performed with the burr device. It was reported that the surgeon could not cut the teeth in two with the burr device. It was reported that the burr was not round enough. It was reported that a competitors (komet) burr was used and the procedure was successfully completed. It was reported that there was a 20 second delay in the procedure due to the event. There was patient involvement reported. There were no reports of injuries, medical intervention or prolonged hospitalization. It was reported that this was the first time that the surgeon used this type of burr device (depuy synthes). It was reported that the surgeon usually uses komet burrs. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-64614 |
| MDR Report Key | 8647389 |
| Date Received | 2019-05-28 |
| Date of Report | 2019-05-14 |
| Date of Event | 2019-05-10 |
| Date Mfgr Received | 2019-05-14 |
| Date Added to Maude | 2019-05-28 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF 4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 4436 |
| Manufacturer Phone | 6103142063 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BURR ROUND M DIAMETER 2.5MM |
| Generic Name | BURR, SURGICAL, GENERAL AND PLASTIC SURGERY |
| Product Code | GFF |
| Date Received | 2019-05-28 |
| Catalog Number | 03.000.007S |
| Lot Number | 2L56444 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES PRODUCTS LLC |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-28 |