MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-03-31 for UNIVERSAL DRILL KEY manufactured by Materialise Dental Nv.
[1641314]
Doctor used a so-called "universal guide" with the wrong components. In normal circumstances, using the right components, doctor would have operated as follows: doctor would have positioned drill guide in the mouth of the patient. Doctor would have inserted the correct components into the guide inside the mouth of the patient. Doctor would have placed drills inside the components and would have been able to drill accurately, guided by the combination of the right guide with the right components. The doctor experienced that the components did not fit the drill guide, so step could not be performed. Instead of cancelling surgery, doctor continued without the components and placed implants in the wrong position.
Patient Sequence No: 1, Text Type: D, B5
[8595945]
The root cause is use error. The instructions for use call out on the doctor to check availability of the correct components prior to surgery. Doctor failed to meet that request and ended up performing surgery with the wrong components. (this is precaution #1 in the instruction for use).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121772-2010-00003 |
| MDR Report Key | 1652495 |
| Report Source | 05 |
| Date Received | 2010-03-31 |
| Date of Report | 2010-03-29 |
| Date of Event | 2010-03-05 |
| Date Mfgr Received | 2010-03-05 |
| Date Added to Maude | 2010-04-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | TECHNOLOGIELANN 15 |
| Manufacturer City | LEUVEN 3001 |
| Manufacturer Country | BE |
| Manufacturer Postal | 3001 |
| Manufacturer Phone | 6396711 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL DRILL KEY |
| Generic Name | UNIVERSAL DRILL KEY |
| Product Code | LXI |
| Date Received | 2010-03-31 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | 1733610 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MATERIALISE DENTAL NV |
| Manufacturer Address | TECHNOLOGIELAAN 15 LEUVEN 3001 BE 3001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-03-31 |