MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-12-21 for SURGICASE CONNECT, SURGICASE GUIDE manufactured by Materialise Nv.
[3059892]
It was reported that the pt underwent a extra-articular radius osteotomy of the right side utilizing the surgicase guide to predrill holes for the plate and to cut the wedge for the osteotomy. During surgery it became apparent that the guide did not fit the pt anatomy because the included model representing the radius represented a left side radius. Therefore,the guide could not be used to drill or cut. The surgeon reverted to traditional instruments to perform the surgery. There was no serious injury of the pt nor a significant increase in surgery time reported because of this event.
Patient Sequence No: 1, Text Type: D, B5
[10498095]
The root cause was identified after a review of the internal documentation. During the preparation of the rec'd pt images for 3d conversion, the images were mirrored. Because of this, the resulting 3d model used to design the guide, was also mirrored, resulting in a 3d model and guide appearing to be design for a left hand side. This was no identified during plan approval with the surgeon or during quality inspection.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003998208-2012-00015 |
| MDR Report Key | 2888845 |
| Report Source | 07 |
| Date Received | 2012-12-21 |
| Date of Report | 2012-11-29 |
| Date of Event | 2012-11-29 |
| Date Mfgr Received | 2012-11-29 |
| Device Manufacturer Date | 2012-11-01 |
| Date Added to Maude | 2013-03-25 |
| 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 Contact | THOMAS GULINCK |
| Manufacturer Street | TECHNOLOGIELAAN 15 |
| Manufacturer City | LEUVEN 3001 |
| Manufacturer Country | BE |
| Manufacturer Postal | 3001 |
| Manufacturer Phone | 6396666 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGICASE CONNECT, SURGICASE GUIDE |
| Product Code | PBF |
| Date Received | 2012-12-21 |
| ID Number | 222445 |
| Device Expiration Date | 2013-04-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MATERIALISE NV |
| Manufacturer Address | LEUVEN BE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-21 |