MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-15 for PLANSCAN PLANSCAN SCANNER TIP - STANDARD C12370903 manufactured by D4d Technologies, Llc.
[77834475]
Patient Sequence No: 1, Text Type: N, H10
[77834476]
Per (b)(6), item that cracked while in the patients mouth. Blood was under the crack and when they got it out it shattered at the tip of the screen and plastic. (b)(6) 2017 at 10:55 a. M. (b)(6) left message with (b)(4) at front desk for (b)(6) to call back. At 3:36 p. M. Called again and spoke with (b)(4) at the office and (b)(6) was with patients but will be given message to cal. Then at 4:58 p. M. (b)(4) spoke with (b)(4) at the office and she provided (b)(6)'s email which an e-mail was sent for additional information. At 5:51 p. M. (b)(6) responded to the e-mail sent and provided some additional information. She said that the part of the planscan scanner that cracked is the internal mirror and the edge of the outer rim at the tip of the scanner. The procedure the doctor was performing at the time was intraoral scanning for the same day seat crown. She is not aware of any pieces that fell as a result of the crack. She could not see the lot number or serial number as it looks like its on the inside of the neck. The patient is doing fine as of today.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004998675-2017-00001 |
| MDR Report Key | 6645328 |
| Date Received | 2017-06-15 |
| Date of Report | 2017-06-12 |
| Date of Event | 2017-05-12 |
| Date Mfgr Received | 2017-05-17 |
| Date Added to Maude | 2017-06-15 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. EDDIE ANDERSON |
| Manufacturer Street | 650 INTERNATIONAL PARKWAY |
| Manufacturer City | RICHARDSON TX 75081 |
| Manufacturer Country | US |
| Manufacturer Postal | 75081 |
| Manufacturer Phone | 9722343880 |
| Manufacturer G1 | D4D TECHNOLOGIES, LLC |
| Manufacturer Street | 650 INTERNATIONAL PARKWAY |
| Manufacturer City | RICHARDSON TX 75081 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75081 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PLANSCAN |
| Generic Name | NOF - OPTICAL IMPRESSION SYSTEM FOR CAD/CAM OF DENTAL RESTORATIONS |
| Product Code | NOF |
| Date Received | 2017-06-15 |
| Returned To Mfg | 2017-05-22 |
| Model Number | PLANSCAN SCANNER TIP - STANDARD |
| Catalog Number | C12370903 |
| Lot Number | UNKNOWN |
| Operator | DENTAL ASSISTANT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D4D TECHNOLOGIES, LLC |
| Manufacturer Address | 650 INTERNATIONAL PARKWAY RICHARDSON TX 75081 US 75081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-15 |