MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-06-14 for DRILL GUIDE 220-0057 manufactured by Osteomed.
[20347161]
Pt undergoing mandibular osteotomy. This is a surgery which uses a percutaneous incision through the cheek. A drill guide is used to isolate the soft tissue, and the drill invented into drill guide to perform the necessary cuts. This procedure usually leaves a small scar at the percutaneous site. Same patients elect to have the scar rinsed for cosmetic reasons. In this case, the drill guide overheated due to frictional contact with drill, resulting in a burn at the site. Co informed in 2006 that pt wants plastic surgery for revision of burn at percutaneous site.
Patient Sequence No: 1, Text Type: D, B5
[20608769]
The drill guide is designed to rpovide a channel for the drill inserted through the pt's cheek. It is desirable to keep this diameter as small as reasonable to minimize tissue trauma as a result of the incision / allow healing iwth a small scar. If the drill is angled while applying presure, the dril can contact the surface of the drill guide, resulting in friction and overheating at the tissue site. This could lead to a burn in the area where the drill is angled. The device is designed to have the drill go straight through. On dimensioned reinspection, the returned drill guide met sepcification. The product in questions was discontinued in may 2005 and is no longer available for sales.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027754-2006-00005 |
| MDR Report Key | 726051 |
| Report Source | 07 |
| Date Received | 2006-06-14 |
| Date of Report | 2006-06-14 |
| Date of Event | 2005-12-14 |
| Date Mfgr Received | 2006-05-15 |
| Date Added to Maude | 2006-06-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | R. ELLIS |
| Manufacturer Street | 3885 ANAPAHO RD |
| Manufacturer City | ADDISON TX 75001 |
| Manufacturer Country | US |
| Manufacturer Postal | 75001 |
| Manufacturer Phone | 9726774787 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRILL GUIDE |
| Generic Name | DRILL GUIDE (INSTRUMENT) |
| Product Code | LXI |
| Date Received | 2006-06-14 |
| Returned To Mfg | 2006-06-05 |
| Model Number | 220-0057 |
| Catalog Number | 220-0057 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 714290 |
| Manufacturer | OSTEOMED |
| Manufacturer Address | * ADDISON TX 75001 US |
| Baseline Brand Name | DRILL GUIDE |
| Baseline Generic Name | DRILL GUIDE (INSTRUMENT) |
| Baseline Model No | 220-0057 |
| Baseline Catalog No | 220-0057 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-06-14 |