MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-07-07 for VSPR manufactured by 3d Systems, Inc..
[49021899]
Mdr filing outside of 30 days due to delays in obtaining webtrader account. Not returned.
Patient Sequence No: 1, Text Type: N, H10
[49021900]
A vsp reconstruction fibula cutting guide was designed for a three segment reconstruction of the mandible instead of a four segment reconstruction as required by the surgical plan. Investigation into the digital design of the vspr fibula cutting guide shows the part was designed incorrectly with six saw slots for a total of three fibula segments. The surgical plan discussed during the virtual surgical planning session involved a four fibula segment reconstruction. After the virtual surgical planning session, vspr planning personnel exported the. Stl files for the four fibula segments into the "sgc exported stls" (sgc is an acronym for surgicase, the program used for planning of vspr cases) folder and used the proper file naming convention. For the design of parts, vsp design personnel brought all four fibula segment. Stls into 3d systems freeform software. During the design of fibula cutting guides, at various times fibula segments may be temporarily "hidden" for purposes of a cleaner workspace while focusing on a specific aspect of the guide. The left most fibula segment was hidden, and never unhidden, thus the fibula cutting guide was designed for three fibula segments instead of four. The vspr case report correctly showed the four segment reconstruction on the cover page and the page displaying the postoperative anatomy, as these images are created by planning personnel after the vspr planning session. However, the fibula cutting guide page of the case report showed the incorrectly designed fibula cutting guide. The fibula cutting guide's design error was not caught during final inspection by vspr final inspection personnel, nor was it caught during separate digital checks of the vspr case report by both vspr planning personnel and quality personnel. The case report was approved by one of the surgeons on the case, and the fibula cutting guide was used to make cuts on the patient's proximal fibula. The error caused a delay in surgery, but the surgeon indicated he believes the patient will have no problems clinically as a result of the fibula cutting guide's design error.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1724955-2016-00001 |
| MDR Report Key | 5776920 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-07-07 |
| Date of Report | 2016-07-07 |
| Date of Event | 2016-05-16 |
| Date Mfgr Received | 2016-05-16 |
| Device Manufacturer Date | 2016-05-10 |
| Date Added to Maude | 2016-07-07 |
| 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 | 3 |
| Manufacturer Contact | MR. SCOTT BREWER |
| Manufacturer Street | 5381 SOUTH ALKIRE CIRCLE |
| Manufacturer City | LITTLETON CO 80127 |
| Manufacturer Country | US |
| Manufacturer Postal | 80127 |
| Manufacturer Phone | 7206431001 |
| Manufacturer G1 | 3D SYSTEMS, INC. |
| Manufacturer Street | 5381 SOUTH ALKIRE CIRCLE |
| Manufacturer City | LITTLETON CO 80127 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80127 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VSPR |
| Generic Name | BONE CUTTING INSTRUMENT AND ACCESSORIES |
| Product Code | DZJ |
| Date Received | 2016-07-07 |
| Model Number | VSPR |
| Lot Number | 70509 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3D SYSTEMS, INC. |
| Manufacturer Address | 5381 SOUTH ALKIRE CIRCLE LITTLETON CO 80127 US 80127 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-07-07 |