MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-22 for BONE PROFILER MK-0059 manufactured by Mis Implants Technologies Ltd..
[73456044]
Therefore, because a serious injury resulted, this event is reportable per 21cfr part 803. The device is available for evaluation, though results are not available as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[73456045]
It was reported that a doctor placed a dental implant and was going to use a bone profiler so he could put a multi-unit on it. When putting the bone profiler pin in the implant and using the drill he was not able to remove the pin. When using the drill once again the implant came out altogether. The doctor was able to immediately place a new dental implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004203816-2017-00001 |
| MDR Report Key | 6513651 |
| Date Received | 2017-04-22 |
| Date of Report | 2017-04-21 |
| Date of Event | 2017-02-01 |
| Date Mfgr Received | 2017-03-23 |
| Date Added to Maude | 2017-04-22 |
| 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 | MRS. HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457551 |
| Manufacturer G1 | MIS IMPLANTS TECHNOLOGIES LTD. |
| Manufacturer Street | P.O. BOX 7 BAR LEV INDUSTRIAL PARK |
| Manufacturer City | HA ZAFON, 2015600 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 2015600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BONE PROFILER |
| Generic Name | DRILL, DENTAL, INTRAORAL |
| Product Code | DZA |
| Date Received | 2017-04-22 |
| Returned To Mfg | 2017-04-11 |
| Model Number | NA |
| Catalog Number | MK-0059 |
| Lot Number | W15009619 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIS IMPLANTS TECHNOLOGIES LTD. |
| Manufacturer Address | P.O. BOX 7 BAR LEV INDUSTRIAL PARK HA ZAFON, 2015600 IS 2015600 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-04-22 |