MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-11-14 for VSP SYSTEM VSPR manufactured by 3d Systems.
[59772298]
Not returned.
Patient Sequence No: 1, Text Type: N, H10
[59772299]
Summary: a sales representative contacted 3d systems on (b)(6) 2015 after operating surgeon reported that the fibula reconstruction seemed "short" in the mandible. The sales rep. Explained that the surgeon seemed to think the width of the fibula reconstruction should be the height and the height should be the width. This essentially meant that the lateral surface of the fibula was not facing buccal, but in fact was facing superior procedure at time of incident: mandible reconstruction using fibula free flap. The surgeons adjusted the dissected fibula resulting in a 1-hour increase to surgery time. 3d systems employee (b)(6) received a call from stryker sales representative (b)(6) on 10/13/2016 stating that dr. (b)(6) was confused and unhappy with the fibula reconstruction. Mr. (b)(6) explained that dr. (b)(6) seemed to think the width of the fibula reconstruction should be the height and the height should be the width. This particular fibula cutting guide was designed with cutting slots oriented on the anterior surface of the fibula, not uncommon for defects of this shape and size and per the request of dr. (b)(6) during the planning session. The fibula cutting guide was designed for the left leg, connecting the vessels into the right neck, with plating on the lateral surface. After design, anatomical references (e. G. Directional indicators knee, ankle, lateral, and anterior) are added to the guide to aid with orientation during surgery per wi# (b)(4) vsp guide/template creation. The investigation revealed the cutting guide was labeled incorrectly with knee and ankle indicators transposed. In addition, the lateral and anterior surface indicators were transposed. The cutting guide was fixated to the fibula per orientation indicators resulting in the incorrect placement on the patient's leg. The cutting slots were shifted from an anterior approach to a lateral approach. As a result, the lateral surface of the fibula was no longer facing buccal as planned, but rather superior in the mandible. This resulted in vertically short pieces with increased width and a deviation of the projected plate holes from the mandible cutting guide. The surgeons were able to adjust the dissected fibula resulting in a 1-hour increase in surgery time. Due to the symmetry of the anatomy, the custom plate and the pedicle (not provided by 3d systems) remained viable for the patient. Several follow up attempts were made by vsp reconstruction planning personnel and customer service personnel with dr. (b)(6) in order to discuss the incident, all without success. On 10/28/2016, a (b)(6) was scheduled in which dr. (b)(6) did not sign into. No follow up was able to be performed prior to reporting this event. As a result of the adverse event, an additional inspection step has been added to the process to further verify orientation/labeling at final qc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1724955-2016-00004 |
| MDR Report Key | 6099540 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-11-14 |
| Date of Report | 2016-11-14 |
| Date of Event | 2016-10-13 |
| Date Mfgr Received | 2016-10-13 |
| Device Manufacturer Date | 2016-10-05 |
| Date Added to Maude | 2016-11-14 |
| 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 | 7206431030 |
| Manufacturer G1 | 3D SYSTEMS |
| Manufacturer Street | 5381 SOUTH ALKIRE CIRCLE |
| Manufacturer City | LITTLETON CO 80127 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80127 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VSP SYSTEM |
| Generic Name | VSP RECONSTRUCTION |
| Product Code | DZJ |
| Date Received | 2016-11-14 |
| Model Number | VSPR |
| Lot Number | 76755 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3D SYSTEMS |
| Manufacturer Address | 5381 SOUTH ALKIRE CIRCLE LITTLETON CO 80127 US 80127 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-11-14 |