MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-10-18 for COMPUDENT STA STA-5110 manufactured by Milestone Scientific.
[2340473]
A compudent-sta instrument was used in conjunction with a wand-sta handpiece to perform a dental anesthetic injection. The dentist purchased a becton dickenson 30 gage 1" needle and installed it on the wand sta hand piece. The dentist administered multiple injections using zorcain, marcaine and lidocaine using a 30g x 1" bd luer lock needle attached to the wand sta hand piece. During an injection between teeth #20 and #21 the dentist heard the needle snap off in the pts mouth. The dentist reported that he tried feeling for the needle in the pts mouth without success. The dentist took panorex x rays to see where the needle was situated in the jaw. Pt has been referred to an oral surgeon.
Patient Sequence No: 1, Text Type: D, B5
[9317801]
Milestone was only able to review the narrative from the dentist. Neither the equipment or the needle were returned for evaluation. However, the dentist did state the milestone equipment did not malfunction and operated correctly. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004082685-2011-00004 |
| MDR Report Key | 2308978 |
| Report Source | 05 |
| Date Received | 2011-10-18 |
| Date of Report | 2011-10-17 |
| Date of Event | 2011-09-15 |
| Date Mfgr Received | 2011-09-22 |
| Date Added to Maude | 2011-10-27 |
| 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 | STEPHEN SOLOMON |
| Manufacturer Street | 220 S. ORANGE AVE |
| Manufacturer City | LIVINGSTON NJ 07039 |
| Manufacturer Country | US |
| Manufacturer Postal | 07039 |
| Manufacturer Phone | 9735352717 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPUDENT STA |
| Product Code | EJI |
| Date Received | 2011-10-18 |
| Model Number | STA-5110 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MILESTONE SCIENTIFIC |
| Manufacturer Address | 220 S. ORANGE AVE. LIVINGSTON NJ 07039 US 07039 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-10-18 |