MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-12-21 for REPLACE SELECT TAPERED TIU RP 4.3X13MM * 29414 manufactured by Nobel Biocare Ab.
[407539]
In 2005 - a dental implant was placed in tooth location # 28. Subsequently the pt was experiencing paresthesia. About three weeks later - the implant was removed from pt's mouth. Three months later - the clinician was contacted. She stated the pt developed post-operative paresthesia. Afterwards the implant was removed from the pt's mouth and the paresthesia dissolved. The pt was seen post-operative and is doing well with no problem. The pt has since been re-implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027763-2005-11646 |
| MDR Report Key | 657895 |
| Date Received | 2005-12-21 |
| Date of Report | 2005-09-23 |
| Date of Event | 2005-08-23 |
| Date Facility Aware | 2005-11-23 |
| Report Date | 2005-11-01 |
| Date Reported to FDA | 2005-12-21 |
| Date Reported to Mfgr | 2005-12-21 |
| Date Added to Maude | 2006-01-03 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REPLACE SELECT TAPERED TIU RP 4.3X13MM |
| Generic Name | DZE |
| Product Code | DZG |
| Date Received | 2005-12-21 |
| Returned To Mfg | 2005-09-20 |
| Model Number | * |
| Catalog Number | 29414 |
| Lot Number | 654864 |
| ID Number | * |
| Device Expiration Date | 2010-03-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4 MO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 647368 |
| Manufacturer | NOBEL BIOCARE AB |
| Manufacturer Address | DOMBOV 2 KARLSKOGA SW S-691-51 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2005-12-21 |