MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-04-08 for HU-FRIEDY #5 SCHMECKEBIER APEXO ELEVATOR E5 manufactured by .
[3394657]
The dental instrument (elevator) broke during a surgical extraction. The pt was sent to an oral surgeon where they recommended to leave the tip because it will not cause any harm to the pt. The date of birth and weight of the pt were not provided.
Patient Sequence No: 1, Text Type: D, B5
[10613776]
The returned instrument appears to have broken by applying a force higher than material capability of the working end. It is broken at approx 5. 5 mm from the tip. These type of instruments ((b)(4) elevator) have a life expectancy of 7 years and the returned instrument was manufactured in 1986. The returned instrument has exceeded its life expectancy.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416605-2013-00001 |
| MDR Report Key | 3049536 |
| Report Source | 06 |
| Date Received | 2013-04-08 |
| Date of Report | 2013-04-05 |
| Date Mfgr Received | 2013-03-11 |
| Device Manufacturer Date | 1986-01-01 |
| Date Added to Maude | 2013-04-19 |
| 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 | MARIA VRABIE, TEAM LEADER |
| Manufacturer Street | 3232 NORTH ROCKWELL ST |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal | 60618 |
| Manufacturer Phone | 7739753495 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HU-FRIEDY #5 SCHMECKEBIER APEXO ELEVATOR |
| Generic Name | 5 SCHMECKEBIER APEXO ELEVATOR |
| Product Code | EMN |
| Date Received | 2013-04-08 |
| Returned To Mfg | 2013-03-11 |
| Model Number | E5 |
| Catalog Number | E5 |
| Lot Number | 1986 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-04-08 |