MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-06-12 for UNKNOWN_INSTRUMENTSTIRE_PRODUCT UNK_ICO manufactured by Stryker Instruments-kalamazoo.
[110783805]
The quality investigation is complete. Device discarded.
Patient Sequence No: 1, Text Type: N, H10
[110783806]
It was reported that during a procedure on the jaw bone, the bur broke. It was also reported that an additional procedure was required to remove the broken tip of the bur at the end of the procedure. It was further reported that the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2018-01055 |
| MDR Report Key | 7592567 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-06-12 |
| Date of Report | 2018-06-12 |
| Date of Event | 2018-05-14 |
| Date Mfgr Received | 2018-05-21 |
| Date Added to Maude | 2018-06-12 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. UNA BARRY |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Postal | NA |
| Manufacturer Phone | 214532900 |
| Manufacturer G1 | STRYKER INSTRUMENTS-IRELAND |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN_INSTRUMENTSTIRE_PRODUCT |
| Generic Name | BUR, DENTAL |
| Product Code | EJL |
| Date Received | 2018-06-12 |
| Catalog Number | UNK_ICO |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-12 |