MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-01-26 for 301 APEXO ELEVATOR E301 manufactured by Hu-friedy Mfg, Inc..
[1006747]
During a 3rd molar extraction on a young male pt, approx 10mm of an apexo #310 elevator tip broke off and became lodged in between the root of a molar and the floor of the maxillary sinus. The oral surgeon assessed the position of the broken tip and decided not to perform any additional procedures for removal. The pt was sent for a second opinion to an oral surgeon at (b)(6) and was also advised not to have any additional procedures to attempt removal of the tip. Follow-up reports from the oral surgeon indicate that the broken tip has not migrated and that the pt is completely asymptomatic. Hu-friedy manufacturing was made aware of this incident on 12/23/08.
Patient Sequence No: 1, Text Type: D, B5
[8153761]
The broken device was given to the oral surgeon office's sales rep for return to hu-friedy. The device was sent to hu-friedy on 9/10/2008, from the sales rep asking for a warranty replacement of the instrument along with several other instruments, no detail was given about the adverse event. Instruments returned for warranty replacement are scraped and discarded. On 12/23/2008, an e-mail was sent to hu-friedy's customer contact link on our website from the oral surgeon's office inquiring about the chemical content of the e301 elevator. Upon follow-up with the doctor's office, hu-friedy learned of the adverse event and gathered the details needed to file this report. It was not possible to locate the instrument in order to perform an eval due to the time lapse between the e-mail notification about the incident and the actual return of the instrument.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416605-2009-00001 |
| MDR Report Key | 1297049 |
| Report Source | 07 |
| Date Received | 2009-01-26 |
| Date of Report | 2009-01-23 |
| Date of Event | 2008-08-08 |
| Date Mfgr Received | 2008-12-23 |
| Device Manufacturer Date | 2001-08-01 |
| Date Added to Maude | 2010-08-16 |
| 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, MANAGER |
| Manufacturer Street | 3232 NORTH ROCKWELL ST. |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal | 60618 |
| Manufacturer Phone | 7739753975 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 301 APEXO ELEVATOR |
| Generic Name | ELEVATOR, SURGICAL, DENTAL |
| Product Code | EMN |
| Date Received | 2009-01-26 |
| Model Number | E301 |
| Catalog Number | E301 |
| Lot Number | V1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HU-FRIEDY MFG, INC. |
| Manufacturer Address | CHICAGO IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-01-26 |