MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-07-14 for ELEVATOR, WARWICK-JAMES #2 42-576-02 manufactured by Karl Leibinger Gmbh U. Co. Kg.
[19895466]
Doctor was using root/fragment elevator to elevate tooth #16, when instrument fractured near the tip. A small portion of the instrument broke in the palatal socket. Doctor made the decision to leave the broken portion in the pt and complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[19945051]
Elevator has been returned and has been forwarded to manufacturer for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610905-2009-00005 |
| MDR Report Key | 1414664 |
| Report Source | 05 |
| Date Received | 2009-07-14 |
| Date of Report | 2009-07-13 |
| Date of Event | 2009-06-30 |
| Date Added to Maude | 2011-03-28 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ACE KEVENEY |
| Manufacturer Street | 11239 ST JOHNS INDUSTRIAL PKWY SOUTH |
| Manufacturer City | JACKSONVILLE FL 32246 |
| Manufacturer Country | US |
| Manufacturer Postal | 32246 |
| Manufacturer Phone | 8006251557 |
| Manufacturer G1 | KARL LEIBINGER GMBH U. CO. KG |
| Manufacturer Street | KOLBINGER STRABE 10 |
| Manufacturer City | MUHLHEIM D-78570 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-78570 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELEVATOR, WARWICK-JAMES #2 |
| Generic Name | ELEVATOR |
| Product Code | GEG |
| Date Received | 2009-07-14 |
| Returned To Mfg | 2009-07-13 |
| Model Number | 42-576-02 |
| Lot Number | 2D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL LEIBINGER GMBH U. CO. KG |
| Manufacturer Address | KOLBINGER STRABE. 10 MUHLHEIM D-78570 GM D-78570 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-07-14 |