MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2009-12-03 for NAVIGATOR GUIDE manufactured by Materialise Dental Nv.
[20995892]
Surgeon has used wrong surgical guide during surgery. This could have resulted in serious injury to the pt's maxilla.
Patient Sequence No: 1, Text Type: D, B5
[21197224]
On (b)(6) 2009, customer dr. (b)(6), complains that the fit of the guide for pt (b)(6) is totally different than the fit of the prosthesis. Initial investigation on the paperwork and electronic files available at production reveals nothing out of the ordinary. It takes a couple of days before the guide is sent back to hq. Only at that moment can we find out that the guide dr (b)(6) received had been swapped with dr (b)(6) guide for pt (b)(6). These are orders 1724539 and 1724467. By that time (b)(6), dr (b)(6) surgery on pt (b)(6) had happened as planned on (b)(6), using the wrong guide. Further investigation showed that two very similar, mucosa supported, maxillary cases were built the same day. Both were navigator, 4 implants, with fixation screws. Plannings were very similar. During design, the corresponding "ordernumber" is labeled onto the guides, for recognition. However, in this case, a human mistake happened, and one of the employees attached the wrong guide to the wrong case, resulting in a mix-up. So the only thing mixed up was the guide: the doctor received the correct package, with the correct documentation, with the correct reports, and the correct pt name, but with a very similar yet wrong guide. Nevertheless: the fit of the guides was different, so the customer could have discovered the misfit. Apparently, in this case, the customer discovered the misfit, but thought it was caused by resilient mucosa. The pt did not infer any damage other than the fact that his prosthesis could not be fitted on time for surgery. Implants are osseointegrated, there is no evidence of fenestrations or abnormal bleedings. The condition of the pt will be monitored and reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006638827-2009-00001 |
| MDR Report Key | 1561284 |
| Report Source | 01,04 |
| Date Received | 2009-12-03 |
| Date of Report | 2009-12-02 |
| Date of Event | 2009-11-16 |
| Date Mfgr Received | 2009-11-13 |
| Device Manufacturer Date | 2009-11-01 |
| Date Added to Maude | 2011-04-05 |
| 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 | TECHNOLOGIELAAN 15 |
| Manufacturer City | LEUVEN 3001 |
| Manufacturer Country | BE |
| Manufacturer Postal | 3001 |
| Manufacturer Phone | 6396711 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NAVIGATOR GUIDE |
| Generic Name | SURGICAL TEMPLATE |
| Product Code | KMY |
| Date Received | 2009-12-03 |
| Returned To Mfg | 2009-11-17 |
| Model Number | NAVIGATOR GUIDE |
| Lot Number | 1724467 |
| Device Expiration Date | 2010-05-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2009-12-03 |