MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-05-04 for SILHOUETTE IC IMPLANT IITSS412D manufactured by Biolet International Inc..
[615752]
Explant did not integrate.
Patient Sequence No: 1, Text Type: D, B5
[7921910]
Severity: minimal. Frequency: less than 2% of all implants manufactured. The implant does not appear to have been defective in any way.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045056-2007-00038 |
| MDR Report Key | 846260 |
| Report Source | 05,07 |
| Date Received | 2007-05-04 |
| Date of Report | 2007-04-24 |
| Date of Event | 2005-08-12 |
| Date Facility Aware | 2005-08-12 |
| Report Date | 2007-04-24 |
| Date Reported to Mfgr | 2006-10-24 |
| Date Mfgr Received | 2006-11-09 |
| Device Manufacturer Date | 2003-07-01 |
| Date Added to Maude | 2007-05-11 |
| 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 Street | 368 SOUTH MILITARY TRAIL |
| Manufacturer City | DEERFIELD BEACH FL 33442 |
| Manufacturer Country | US |
| Manufacturer Postal | 33442 |
| Manufacturer Phone | 9546989998 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILHOUETTE IC IMPLANT |
| Generic Name | ENDOSSEOUS IMPLANT |
| Product Code | DZS |
| Date Received | 2007-05-04 |
| Returned To Mfg | 2006-10-24 |
| Model Number | IITSS412D |
| Catalog Number | IITSS412D |
| Lot Number | 4640A |
| ID Number | * |
| Device Expiration Date | 2009-07-01 |
| Operator | OTHER |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 833376 |
| Manufacturer | BIOLET INTERNATIONAL INC. |
| Manufacturer Address | * DEERFIELD BEACH FL 33442 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-05-04 |