MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-12-06 for SURGICASE CONNECT, SURGICASE GUIDE manufactured by Materialise N.v..
[2904064]
It was reported that the patient underwent a diaphyseal osteotomy utilizing the surgicase guide to predrill holes for the plate and to cut the wedge for the osteotomy. Difficulty with positioning of the guide resulted in 2 failed attempts to drill the holes for the plate in the right position. The 3rd attempt was successful and the plate was positioned in the planned position on the radius. The surgery on the ulna was performed without any problems. The 2 failed attempts resulted in a delay during surgery of approximately 35 min.
Patient Sequence No: 1, Text Type: D, B5
[10411304]
Surgery was attended by a product engineer who provided extra measurements to allow extra verification of the guide fit. These were not used by the operating surgeon when positioning the guide on the radius. Based on the available information, the conclusion of the investigation shows that failure to follow instructions has caused the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003998208-2012-00014 |
| MDR Report Key | 2864401 |
| Report Source | 07 |
| Date Received | 2012-12-06 |
| Date of Report | 2012-11-06 |
| Date of Event | 2012-11-06 |
| Date Mfgr Received | 2012-11-06 |
| Device Manufacturer Date | 2012-10-01 |
| Date Added to Maude | 2012-12-11 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | THOMAS GULINCK |
| Manufacturer Street | 15 TECHNOLOGIELAAN |
| 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 | 2012-12-06 |
| ID Number | 620913 |
| Device Expiration Date | 2012-11-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MATERIALISE N.V. |
| Manufacturer Address | LEUVEN BE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2012-12-06 |